Application device for a fluid delivery apparatus and method of use

ABSTRACT

An application device for a fluid delivery includes a housing having a bore extending from a bottom of the housing. The bore is sized and shaped for receiving at least a portion of the fluid delivery apparatus. The application device also includes an impact component for impacting the fluid delivery apparatus and moving at least a portion of the fluid delivery apparatus towards a user&#39;s skin. The application device includes a safety arm that is positionable relative to the impact component between a locked configuration in which the impact component is secured in a safety position, and a released configuration in which the impact component is free to move within the housing for impacting the fluid delivery apparatus.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to a fluid delivery apparatus,and more particularly to an applicator for activating the fluid deliverydevice.

BACKGROUND OF THE DISCLOSURE

Numerous apparatus have been developed for transdermal delivery ofmedicines using microneedle assemblies. Microneedle assembliesfacilitate reducing an amount of pain felt by a patient as compared tolarger conventional needles. Moreover, conventional subcutaneous (andoften intra-muscular) delivery of medicines using a needle operates todeliver a large quantity of the medicine at one time, thereby creating aspike in the bioavailability of the medicine. While this is not asignificant problem for some medicines, many medicines benefit fromhaving a steady state concentration in the patient's blood stream.Transdermal delivery apparatus are capable of administering drugs at asubstantially constant rate over an extended period of time.

However, delivery of medicine using transdermal delivery apparatusesposes several challenges. For example, with at least some knowntransdermal delivery apparatuses, the placement of the device withrespect to a user's skin and the amount of force used to attach thedevice to the skin can vary, thereby affecting the ability of themicroneedles to properly penetrate the user's skin. In addition, themedicine may have air bubbles dispersed therethrough, which can alsoaffect the delivery of the medicine through each microneedle of themicroneedle assembly. Moreover, the quantity of the medicine deliveredthrough each microneedle of the microneedle assembly may not be constantor equal due to variances in the pressure supplied to the medicine.

BRIEF DESCRIPTION

In one aspect, an application device for a fluid delivery apparatus isprovided. The application device includes a housing having a boreextending from a bottom of the housing. The bore is sized and shaped forreceiving at least a portion of the fluid delivery apparatus therein.The application device also includes an impact component for impactingthe fluid delivery apparatus and moving at least a portion of the fluiddelivery apparatus towards a user's skin. Moreover, the applicationdevice includes a safety arm positionable relative to the impactcomponent between a locked configuration in which the impact componentis secured in a safety position, and a released configuration in whichthe impact component is free to move within the housing for impactingthe fluid delivery apparatus.

In another aspect, a system is provided. The system includes anapplication device and a fluid delivery apparatus. The applicationdevice includes a housing having a bore extending upward from a bottomof the housing. The bore is sized and shaped for receiving at least aportion of the fluid delivery apparatus therein. The application devicehas a retention member and an impact component positioned within thebore. The impact component is adapted for impacting the fluid deliveryapparatus and moving at least a portion of the fluid delivery apparatustoward a user's skin. The impact component is positionable relative tothe housing between a safety position in which the impact component issecured to the retention member, and a released configuration in whichthe impact component is free to move within the housing for impactingthe fluid delivery apparatus. The application device has a releasecomponent configured to transition the impact component from the safetyposition to the released configuration.

In yet another aspect, a method of activating a fluid delivery apparatusis provided. The fluid delivery apparatus includes a fluid therein and aplurality of microneedles for delivering the fluid to a user via theplurality of microneedles. The method includes positioning the fluiddelivery apparatus relative a portions of the user's body such that theplurality of microneedles are adjacent the user's skin. The method alsoincludes positioning an application device into direct contact with thefluid delivery apparatus. Furthermore, the method includes activatingthe application device to cause a piston of the application device tocontact the fluid delivery apparatus at a predetermined velocity anddrive the plurality of microneedles into the user's skin at a velocityin the range between 4.5 meters/second (m/s) to 6 m/s.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentdisclosure will become better understood when the following detaileddescription is read with reference to the accompanying drawings in whichlike characters represent like parts throughout the drawings, wherein:

FIG. 1A is a sectional view of an exemplary fluid delivery apparatus ina pre-use configuration;

FIG. 1B is a sectional view of the fluid delivery apparatus in apre-activated configuration;

FIG. 2 is an exploded, sectional view of fluid delivery apparatus;

FIG. 3 is a sectional view of a collet assembly of the fluid deliveryapparatus;

FIG. 4 is an exploded, perspective view of the collet assembly shown inFIG. 3;

FIG. 5 is a sectional view of a plenum assembly of the fluid deliveryapparatus;

FIG. 6 is an exploded, perspective view of the plenum assembly;

FIG. 7 is a top view of a sleeve component of the plenum assembly;

FIG. 8 is a bottom view of the sleeve component;

FIG. 9 is a section view of the sleeve component taken about line 9-9shown in FIG. 7;

FIG. 10 is a section view of the sleeve component taken about line 10-10shown in FIG. 8;

FIG. 11 is a top view of a plenum component of the plenum assembly;

FIG. 12 is a bottom view of the plenum component;

FIG. 13 is a section view of the plenum component taken about line 13-13shown in FIG. 11;

FIG. 14 is an exploded, schematic of a plenum cap assembly of the fluiddelivery apparatus;

FIG. 15 is a top view of the plenum cap assembly, showing a firstadhesive layer;

FIG. 16 is a top view of a second adhesive layer of the plenum capassembly;

FIG. 17 is a top view of a third adhesive layer of the plenum capassembly;

FIG. 18 is an exploded, schematic of a microneedle array assembly of thefluid delivery apparatus;

FIG. 19A is a schematic cross-sectional view of the microneedle arrayassembly;

FIG. 19B is a schematic cross-sectional view of the microneedle arrayassembly of FIG. 19A but showing a protective cover covering themicroneedle array assembly;

FIG. 20 is a sectional view of a cartridge assembly of the fluiddelivery apparatus;

FIG. 21 is an exploded, schematic of the cartridge assembly;

FIG. 22 is a sectional view of a cap assembly of the fluid deliveryapparatus;

FIG. 23 is an exploded, perspective view of a mechanical controllerassembly of the fluid delivery apparatus;

FIG. 24 is a perspective view of a body component of the mechanicalcontroller assembly;

FIG. 25 is a top view of the body component;

FIG. 26 is a sectional view of the body component taken about line 26-26of FIG. 25;

FIG. 27 is a sectional view of the body component taken about line 27-27of FIG. 25;

FIG. 28 is a perspective view of a pivoting latch of the mechanicalcontroller assembly;

FIG. 29 is a front perspective view of a retention plate of themechanical controller assembly;

FIG. 30 is a rear perspective view of the retention plate;

FIG. 31 is a perspective section view of the assembled mechanicalcontroller assembly;

FIG. 32 is a top view of the mechanical controller assembly;

FIG. 33 is a sectional view of the mechanical controller assembly takenabout line 33-33 of FIG. 32;

FIG. 34 is a sectional view of the mechanical controller assembly takenabout line 34-34 of FIG. 32;

FIG. 35 is a perspective section view of an insert component of themechanical controller assembly;

FIG. 36 is a perspective view of a band of the fluid delivery apparatus;

FIG. 37 is an enlarged sectional view of a portion of the band capturingthe collet assembly shown in FIG. 4;

FIG. 38 is an enlarged perspective view of the band and collet assemblyshown in FIG. 37, illustrating a first orientation of an indicator in apre-use configuration;

FIG. 39 is an enlarged perspective view similar to FIG. 8, butillustrating a second orientation of the indicator in a useconfiguration;

FIG. 40 is a perspective view of an applicator of the fluid deliveryapparatus;

FIG. 41 is a front sectional view of the applicator shown in FIG. 40;

FIG. 42 is a side sectional view of the applicator shown in FIG. 40;

FIG. 43 is a top sectional view of the applicator taken about line 43-43shown in FIG. 40;

FIG. 44 is a perspective view of a safety arm of the applicator;

FIG. 45 is a front perspective view of a piston of the applicator;

FIG. 46 is a rear perspective view of the piston;

FIG. 47 is a side view of the piston; and

FIG. 48 is a sectional view of the applicator attached to the fluiddelivery apparatus.

Unless otherwise indicated, the drawings provided herein are meant toillustrate features of embodiments of the disclosure. These features arebelieved to be applicable in a wide variety of systems comprising one ormore embodiments of the disclosure. As such, the drawings are not meantto include all additional features known by those of ordinary skill inthe art to be required for the practice of the embodiments disclosedherein.

DETAILED DESCRIPTION

In the following specification and the claims, reference will be made toa number of terms, which shall be defined to have the followingmeanings. The singular forms “a,” “an,” and “the” include pluralreferences unless the context clearly dictates otherwise. The terms“comprising,” “including,” and “having” are intended to be inclusive andmean that there may be additional elements other than the listedelements. “Optional” or “optionally” means that the subsequentlydescribed event or circumstance may or may not occur, and that thedescription includes instances where the event occurs and instanceswhere it does not.

Approximating language, as used herein throughout the specification andclaims, may be applied to modify any quantitative representation thatcould permissibly vary without resulting in a change in the basicfunction to which it is related. Accordingly, a value modified by a termor terms, such as “about,” “approximately,” and “substantially,” are notto be limited to the precise value specified. In at least someinstances, the approximating language may correspond to the precision ofan instrument for measuring the value. Here and throughout thespecification and claims, range limitations may be combined and/orinterchanged; such ranges are identified and include all the sub-rangescontained therein unless context or language indicates otherwise.

As used herein, positional terms such as upward, downward, upper, lower,top, bottom, and the like are used only for convenience to indicaterelative positional relationships.

As used herein, for the purposes of description and claims, the term“fluid” applies only to liquids, and should not be taken to includegaseous products.

FIG. 1A is a sectional view of an exemplary fluid delivery apparatus(e.g., a drug delivery apparatus), indicated generally by 10, in apre-use configuration. FIG. 1B is a sectional view of the fluid deliveryapparatus 10 in a pre-activated configuration. FIG. 2 is an exploded,sectional view of fluid delivery apparatus 10. In the exemplaryembodiment, the fluid delivery apparatus 10 includes a plurality ofsubassembly components coupled together to form the fluid deliveryapparatus 10, including a collet assembly 12 and a fluid distributionassembly 14. The collet assembly 12 and the fluid distribution assembly14 are indicated generally by their respective reference numbers. Asshown in FIG. 2, the fluid distribution assembly 14 includes a pluralityof additional subassembly components, including a plenum assembly 16, acartridge assembly 18, a cap assembly 320, and a mechanical controllerassembly 20. Each of the collet assembly 12, the fluid distributionassembly 14, the plenum assembly 16, the cartridge assembly 18, the capassembly 320, and the mechanical controller assembly 20 is indicatedgenerally in the accompanying drawings by their reference numbers. Thecollet assembly 12 forms the body or housing of the fluid deliveryapparatus 10 and is slidably coupled to the fluid distribution assembly14. To form the fluid distribution assembly 14, the cap assembly 320 iscoupled to the cartridge assembly 18, and the cartridge assembly 18 isslidably coupled to the plenum assembly 16. In addition, the mechanicalcontroller assembly 20, as explained in more detail below, is coupled tothe cartridge assembly 18.

FIG. 3 is a sectional view and FIG. 4 is an exploded, perspective of thecollet assembly 12 of the fluid delivery apparatus 10. Referring toFIGS. 2-4, in the exemplary embodiment, the collet assembly 12 includesa collet 22 coupled to a collet lock 50. In the exemplary embodiment,the collet 22 is formed in a generally frustoconical shape, having ahollow interior space 24 defined therein. The collet 22 is formedgenerally symmetrically about a central axis “A.” An upper rim 26 of thecollet 22 defines an opening 28 to the interior space 24. A cylindricalupper wall 30 extends generally vertically downward from the upper rim26 towards a central portion 32 of the collet 22. A lower wall 34extends downward at an outward angle from the central portion 32 towarda base 36 (or lower edge) of the collet 22. The upper wall 30, centralportion 32, and the lower wall 34 collectively define the interior space24. A step 38 extends around the upper wall 30, defining an outerhorizontal surface 40 (or ledge) configured to engage an attachment band430 (shown in FIG. 36), as is described further herein. The step 38 alsodefines an inner horizontal surface 42 (or step) configured to engagewith the plenum assembly 16 to facilitate properly positioning theplenum assembly 16 above a user's skin surface prior to use of the fluiddelivery apparatus 10.

As illustrated in FIG. 4, the collet 22 includes a pair of notches,indicated generally at 44, opposite each other and formed through thelower wall 34. In the exemplary embodiment, the notches 44 are generallyrectangular in shape and configured to receive a portion of the colletlock 50. In addition, the collet 22 includes one or more stops 46configured to facilitate positioning of the collet lock 50 when coupledto the collet 22. For example, and without limitation, the one or morestops 46 are formed as inward extending projections formed on lower wall34. The stops 46 can have form or shape that enables the stops 46 tofunction as described herein.

As illustrated in FIGS. 3 and 4, the collet 22 includes a plurality offlexible tabs 48 formed integrally with the upper wall 30. In addition,the plurality of flexible tabs 48 are positioned about and equidistantfrom the central axis “A.” In particular, the plurality of flexible tabs48 extend from a first end 76 to an opposite free second end 78. In theexemplary embodiment, the free second end 78 angles radially inward andis configured to engage with the plenum assembly 16 to facilitateproperly positioning the plenum assembly 16 at the user's skin surfaceduring use of the fluid delivery apparatus 10.

As illustrated in FIGS. 3 and 4, in the exemplary embodiment, the colletlock 50 is generally ring-shaped, having a convex inner surface 52extending from a lower outer edge 54 of the collet lock 50 to agenerally cylindrical inner wall 56. The inner wall 56 extends upward toan upper surface 58. The collet lock 50 includes a generally cylindricalouter wall 60 that is concentric with inner wall 56 and extends upwardfrom the lower outer edge 54. In addition, the collet lock 50 includeslatching members 62, 64, opposite each other and extending upward fromthe upper surface 58. The latching members 62, 64 are configured tocouple to the notches 44 of the collet 22. The latch member 62 includesa first coupling member 66 that extends outward from latch member 62. Inparticular, the first coupling member 66 includes a neck portion 63 thatextends at an upward angle substantially perpendicular to the lower wall34 of the collet 22. In addition, the first coupling member 66 includesa head portion 65 that extends generally parallel to the lower wall 34beyond a periphery of the neck portion 63. Furthermore, the firstcoupling member 66 includes a window or aperture 61 extending throughthe head portion 65. The window 61 is configured to present anindication to the user of the fluid delivery apparatus 10 of a tightnessof the attachment band 430, as is further described herein.

Similarly, the latching member 64 includes an adjacent pair of secondcoupling members 68 that extend outward from latching member 64. In theexemplary embodiment, the coupling members 68 each include a neckportion 67 that extends at an upward angle substantially perpendicularto the lower wall 34 of the collet 22. In addition, the second couplingmembers 68 include a head portion 69 that extends generally parallel tothe lower wall 34 beyond a periphery of the neck portion 67. The firstcoupling member 66 and the pair of second coupling members 68 areconfigured to engage the attachment band 430, as is described furtherherein.

In the exemplary embodiment, the outer wall 60 of the collet lock 50includes an upper outer surface 70 that inclines inward at an anglesubstantially parallel to the lower wall 34 to facilitate face-to-faceengagement therewith. In addition, the upper surface 58 includes aplurality of stop members 72 that extend upward and are configured toengage the one or more stops 46 of the collet 22 to facilitate properlypositioning of the collet lock 50 when coupled to the collet 22.Extending radially inward from the convex inner surface 52 is aplurality of tabs 74 configured to engage with the plenum assembly 16 tofacilitate properly positioning the plenum assembly 16 at the user'sskin surface during use of the fluid delivery apparatus 10.

In the exemplary embodiment, the collet 22 is coupled to the collet lock50 to form a unitary assembly (shown in FIG. 3). In particular, theupper surface 70 and the latching members 62, 64 of the collet lock 50engage the lower wall 34 and the notches 44 of the collet 22 via apermanent coupling method, for example, and without limitation, via anadhesive bond, a weld joint (e.g., spin welding, ultrasonic welding,laser welding, or heat staking), and the like. Alternatively, the collet22 and the collet lock 50 may be coupled together using any connectiontechnique that enables the formation of the collet assembly 12.

FIG. 5 is a sectional view of the plenum assembly 16 of the fluiddelivery apparatus 10. FIG. 6 is an exploded, perspective view of theplenum assembly 16. In the exemplary embodiment, the plenum assembly 16includes a sleeve component 100, a plenum component 102, a cannula 104,a plenum cap assembly 106 (broadly, “a gas extraction device”), and amicroneedle array assembly 108 coupled together to form the unitaryplenum assembly 16. In particular, the sleeve component 100 is coupledto the plenum component 102 to define a cavity 110 therein. In theexemplary embodiment, the sleeve component 100 is coupled to the plenumcomponent 102 for example, and without limitation, via an adhesive bond,a weld joint (e.g., spin welding, ultrasonic welding, laser welding, orheat staking), and the like. Alternatively, the sleeve component 100 andthe plenum component 102 may be coupled together using any connectiontechnique that enables the formation of the plenum assembly 16.

FIG. 7 is a top view of the sleeve component 100, FIG. 8 is a bottomview of the sleeve component 100, FIG. 9 is a section view of the sleevecomponent 100 taken about line 9-9 shown in FIG. 7, and FIG. 10 is asection view of the sleeve component 100 taken about line 10-10 shown inFIG. 8. As illustrated in FIGS. 5-10, in the exemplary embodiment, thesleeve component 100 includes a lower annular wall portion 112 and anupper annular wall portion 114. The upper annular wall portion 114includes a plurality of flexible tabs 116 that extend substantiallyaxially about the central axis “A” of the sleeve component 100 and areformed integrally with the upper wall portion 114. The plurality offlexible tabs 116 are positioned equidistant about the central axis “A”with respect to each other. While four flexible tabs 116 are shown inthe figures, it is noted that in other embodiments the sleeve component100 has any number of the flexible tabs 116 that enable the sleevecomponent 100 to function as described herein. In the exemplaryembodiment, each flexible tab 116 extends from a first end 118 to anopposite free second end 120. The free second end 120 includes aradially inward extending protrusion 122 that is positioned to engagethe cartridge assembly 18 to facilitate properly positioning thecartridge assembly 18 in the pre-use and pre-activated configurations.

As illustrated in FIG. 7, the lower wall portion 112 has an outerdiameter 124 and an inner diameter 126, between which a plurality ofrecesses 128, 130, 132 are defined. While four sets of recesses 128,130, 132, positioned equidistant about the central axis “A,” are shownin the figures, it is noted that in other embodiments the sleevecomponent 100 has any number of sets of recesses 128, 130, 132 thatenables the sleeve component 100 to function as described herein. Thelower wall portion 112 also includes a plurality of inwardly extendingflange members 134 positioned equidistant about central axis “A.” Fourflange members 134 are shown in the figures, however, it is noted thatin other embodiments, the sleeve component 100 has any number of flangemembers 134 that enables the sleeve component 100 to function asdescribed herein. In the exemplary embodiment, the flange members 134are configured to engage and couple to corresponding recesses 190 formedin the plenum component 102.

In the exemplary embodiment, a respective recess 128 (or pocket) isformed as a generally rectangular-shaped recess in the lower wallportion 112, extending from the outer diameter 124 a predefined radialdistance 138 into the lower wall portion 112. As illustrated in FIG. 8,the recess 128 is offset circumferentially from the center of arespective flange member 134 at an angle α. As best illustrated in FIG.10, the recess 128 extends upwardly from a bottom surface 136 of thesleeve component 100 a predetermined distance 140, and is configured toreceive a respective tab 74 of the collet lock 50 therein.

Furthermore, in the exemplary embodiment, a respective recess 130 isformed as a flat surface formed in the lower wall portion 112, whereinthe recess 130 extends from the bottom surface 136 to a top surface 142(or ledge) of the lower wall portion 112 and is substantiallyperpendicular to a radial line extending from the central axis “A.” Asillustrated in FIG. 8, the recess 130 is formed substantiallyperpendicular to a radial line defined at an angle β from the center ofa respective flange member 134. In the exemplary embodiment, the recess130 is configured to enable a respective tab 74 of the collet lock 50 topass in an axial direction without interference with the sleevecomponent 100 during assembly of the plenum assembly 16 with the colletassembly 12.

Moreover, in the exemplary embodiment, a respective recess 132 is formedas an arcuate recess that extends tangentially from the recess 130 in acircumferential direction and with a continuous radius with respect tothe central axis “A.” In particular, the recess 132 extendscircumferentially an arcuate distance that allows a respective tab 74 ofthe collet lock 50 to be received therein, while simultaneously allowinga respective flexible tab 48 of the collet 22 to align with, and bereceived by, the recess 130 during assembly of the plenum assembly 16with the collet assembly 12. As illustrated in FIG. 6, the recess 132extends upwardly from the bottom surface 136 a predetermined height 144.

The lower wall portion 112 also includes a plurality of protrusions orstops 146 defined in part by recesses 128, 130, 132. In the exemplaryembodiment, each of the stops 146 extends between a circumferential endportion 148 of the recess 132 and an adjacent recess 128 (shown in FIG.8). The stops 146 are configured to prevent rotation of the plenumassembly 16 when the tabs 74 of the collet lock 50 are located in therecesses 128 or at the circumferential end portions 148 of the recesses132. Each of the stops 146 includes an outer surface 150 that extendsgenerally axially and is substantially perpendicular to a radial lineextending from the central axis “A.” In addition, each of the stops 146includes an inclined surface 152 that extends upwardly from the outersurface 150 to the top surface 142 of the lower wall portion 112. Thestops 146 are configured to engage the flexible tabs 48 of the collet 22to facilitate preventing rotation of the plenum assembly 16 with respectto the collet assembly 12 after assembly of the fluid delivery apparatus10. As illustrated in FIG. 6, a portion of the surface of the recess 130extends circumferentially over the recess 132 and couples to theinclined surface 152, thereby functioning as a ramp configured to engagethe flexible tabs 48 of the collet 22 during assembly of the plenumassembly 16 to the collet assembly 12.

FIG. 11 is a top view of the plenum component 102, FIG. 12 is a bottomview of the plenum component 102, and FIG. 13 is a section view of theplenum component 102 taken about line 13-13 shown in FIG. 11. Referringto FIGS. 5,6, and 11-13, in the exemplary embodiment, the plenumcomponent 102 includes a generally planar annular disk body portion 160that extends horizontally across the lower wall portion 112 of thesleeve component 100 adjacent the bottom surface 136 to define thecavity 110. The body includes an upper surface 162 (FIG. 11) and anopposite lower surface 164 (FIG. 12). The upper surface 162 of theplenum component 102 has an upwardly extending annular central wall 166positioned proximate a central portion of the body portion 160 anddefining a chamber 167. The annular central wall 166 includes an upperrim 168 that is configured to couple to the cartridge assembly 18. Thelower surface 164 of the plenum component 102 includes a rectangularframe portion 170 that extends downwardly from the body portion 160. Theframe portion 170 defines a mounting space 172 for coupling the plenumcap assembly 106 and the microneedle array assembly 108 to a mountingsurface 174 located within the mounting space 172.

The plenum component 102 includes an arcuate channel 176 having aplurality of axially extending apertures 178 defined therein. Inparticular, as best illustrated in FIG. 12, the arcuate channel 176 isdefined in the mounting surface 174 within the mounting space 172. Thearcuate channel 176 has a predetermined width that is centered about acenter radius 180. The center radius 180 is concentric with the centralaxis “A” of the plenum component 102. In the exemplary embodiment, thearcuate channel 176 extends circumferentially about 270°. In otherembodiments, the arcuate channel 176 can extend any circumferentialangle that enables the plenum component 102 to function as describedherein. In the exemplary embodiment, the axially extending apertures 178are uniformly disposed in the arcuate channel 176. Each aperture 178 iscentered on the center radius 180 and extends through the body portion160 from the lower surface 164 to the upper surface 162. In theexemplary embodiment, the plenum component 102 includes ten axiallyextending apertures 178. Alternatively, in other suitable embodiments,the plenum component 102 can include any number of axially extendingapertures 178 that enables the plenum component 102 to function asdescribed herein.

In the exemplary embodiment, as best shown in FIG. 5, the cannula 104 iscoupled to a mount 184 that extends upwardly from the upper surface 162of the plenum component 102. In particular, the cannula 104 is coupledin fluid communication to a fluid passage 186 that extends through theplenum component 102, coaxial with the central axis “A.” The cannula 104is coupled to the plenum component 102 via an interference fit with themount 184 and an adhesive disposed in a cavity 188 defined in the mount184. As used herein, the phrase “interference fit” means a value oftightness between the cannula 104 and the mount 184, i.e., an amount ofradial clearance between the components. A negative amount of clearanceis commonly referred to as a press fit, where the magnitude ofinterference determines whether the fit is a light interference fit orinterference fit. A small amount of positive clearance is referred to asa loose or sliding fit. Alternatively, the cannula 104 may be coupled tothe mount 184 using any suitable fastening technique that enables theplenum component 102 to function as described herein. In the exemplaryembodiment, an upper portion the cannula 104 is sharply pointed andextends upwardly away from the plenum component 102, such that thecannula 104 can pierce a portion of the cartridge assembly 18, as isdescribed herein.

Referring to FIG. 11, the plenum component 102 includes a plurality ofrecesses 190 defined in the upper surface 162 and positioned equidistantabout the central axis “A.” The recesses 190 are sized and shaped tocorrespond to the flange members 134 of the sleeve component 100, asdescribed above. Specifically, in the exemplary embodiment, the plenumcomponent 102 includes four recesses 190 shown in the figures, however,it is noted that in other embodiments, the plenum component 102 has anynumber of recesses 190 that enables the plenum component 102 to functionas described herein. As described herein, the sleeve component 100 iscoupled to the plenum component 102 for example, and without limitation,via an adhesive bond, a weld joint (e.g., spin welding, ultrasonicwelding, laser welding, or heat staking), and the like. In particular,the flange members 134 of the sleeve component 100 are coupled to therecesses 190 of the plenum component 102 to form a unitary assembly.

FIG. 14 is an exploded, schematic of the plenum cap assembly 106 of thefluid delivery apparatus 10 shown in FIG. 1A. FIG. 15 is a top view ofthe plenum cap assembly 106. In the exemplary embodiment, the plenum capassembly 106 is a unitary assembly comprising a plurality of layersbonded together. The plenum cap assembly 106 is bonded to the mountingsurface 174 of the plenum component 102 via a first adhesive layer 192,which is fabricated from pressure-sensitive adhesive film. The firstadhesive layer 192 includes an arcuate slot 202 defined therethrough.The arcuate slot 202 is positioned substantially concentric with anaperture 204 formed coaxial with the central axis “A.” The arcuate slot202 has a predetermined width that is centered about a center radius206. The center radius 206 is concentric with the central axis “A.” Inthe exemplary embodiment, the arcuate slot 202 extends circumferentiallyat an angle θ. In other embodiments, the arcuate slot 202 can extend anycircumferential angle θ that enables the plenum cap assembly 106 tofunction as described herein. In the exemplary embodiment, the arcuateslot 202 is configured to at least partially correspond to the arcuatechannel 176 of the plenum component 102 and the aperture 204 ispositioned to correspond to the fluid passage 186.

The plenum cap assembly 106 includes a vent membrane 194 coupled to thefirst adhesive layer 192 opposite the plenum component 102. In theexemplary embodiment, the vent membrane 194 includes a fluid inletaperture 208 formed coaxial with the central axis “A.” In the exemplaryembodiment, the aperture 208 is substantially the same size as theaperture 204 of the first adhesive layer 192. In one suitableembodiment, the vent membrane 194 is fabricated from a gas permeableoleophobic/hydrophobic material. It is understood that other types ofsuitable materials can be used in other embodiments. For example, andwithout limitation, in one embodiment, the vent membrane 194 isfabricated from an acrylic copolymer membrane formed on a nylon supportmaterial, such as Versapor® R Membrane available from Pall Corporationin Port Washington, N.Y. In the exemplary embodiment, the pore size ofvent membrane 194 is about 0.2 microns. The vent membrane 194 has a flowrate for air in the range between about 200milliliters/minute/centimeter² (mL/min/cm²) and about 2000 mL/min/cm²),as measured at about 150 kilopascal (kPa). In addition, the ventmembrane 194 has a minimum fluid bubble pressure in the range betweenabout 35 kilopascal (kPa) and about 300 kPa. In one suitable embodiment,the vent membrane 194 has a flow rate for air of at least 250mL/min/cm², as measured at about 150 kPa, and a minimum fluid bubblepressure of at least 150 kPa. Alternatively, the vent membrane 194 canbe fabricated from any gas permeable material that enables the plenumcap assembly 106 to function as described herein.

FIG. 16 is a top view of a second adhesive layer 196 of the plenum capassembly 106. In the exemplary embodiment, the second adhesive layer 196is formed from a pressure-sensitive adhesive film and is coupled to thevent membrane 194 opposite the first adhesive layer 192. The secondadhesive layer 196 is formed similarly to the first adhesive layer 192and includes an arcuate slot 210 defined therethrough. The arcuate slot210 is configured to form a tortuous flow path that extends generallyperpendicular to the central axis “A” to facilitate removing gas fromthe fluid. The arcuate slot 210 is sized and positioned to substantiallycorrespond to the slot 202 of the first adhesive layer 192. The slot 210is positioned concentric with a central aperture portion 212, which isformed coaxial with the central axis “A.” A first end 214 of the arcuateslot 210 is connected to the central aperture portion 212 with a linearslot portion 216. The arcuate slot 210 has a predetermined width that iscentered about a center radius 218, which corresponds to the centerradius 206 of the first adhesive layer 192. In the exemplary embodiment,the arcuate slot 210 extends circumferentially at the same angle θ asthe arcuate slot 202. In other embodiments, the arcuate slot 210 canextend any circumferential angle that enables the plenum cap assembly106 to function as described herein.

The plenum cap assembly 106 includes an impermeable membrane 198 coupledto the second adhesive layer 196 opposite the vent membrane 194. In theexemplary embodiment, the impermeable membrane 198 includes a fluidaperture 222 formed coaxial with a second end 220 of the arcuate slot210. In the exemplary embodiment, the aperture 222 is substantially thesame size as the apertures 204, 208 of the first adhesive layer 192 andthe vent membrane 194, respectively. The impermeable membrane 198 isfabricated from a gas and liquid impermeable material. For example, andwithout limitation, in one embodiment, the impermeable membrane 198 isfabricated from a polyethylene terephthalate (PET) film. Alternatively,the impermeable membrane 198 can be fabricated from any gas and liquidimpermeable material that enables the plenum cap assembly 106 tofunction as described herein

FIG. 17 is a top view of a third adhesive layer 200 of the plenum capassembly 106. In the exemplary embodiment, the third adhesive layer 200is formed from a pressure-sensitive adhesive film and is coupled to theimpermeable membrane 198 opposite the second adhesive layer 196. Thethird adhesive layer 200 includes a slot 224 defined therethrough. Theslot 224 includes a first end 226 that is sized and positioned tosubstantially correspond to the aperture 222 of the impermeable membrane198. In addition the slot extends from the first end 226 to a second end228, which includes a full radius end sized substantially similar to theapertures 204, 208 of the first adhesive layer 192 and the vent membrane194, respectively. Moreover, the second end 228 is positionedsubstantially coaxial with the central axis “A.”

As described herein with respect to FIGS. 5 and 6, the plenum assembly16 includes the microneedle array assembly 108 coupled to the plenum capassembly 106, which is mounted to the mounting surface 174 of the plenumcomponent 102. FIG. 18 is an exploded, schematic of the microneedlearray assembly 108 of the fluid delivery apparatus 10 shown in FIG. 1A.FIG. 19A is a schematic cross-sectional view of the microneedle arrayassembly 108. In the exemplary embodiment, the microneedle arrayassembly 108 is bonded to the plenum cap assembly 106 via the thirdadhesive layer 200 of the plenum cap assembly 106. The microneedle arrayassembly 108 includes a microneedle array 230 and a membrane 232 drapedat least partially across a plurality of microneedles 234 and a basesurface 236 of the microneedle array 230. The microneedle array assembly108 also includes a distribution manifold 238 that extends across a backsurface 240 of the microneedle array 230 and is bonded thereto by anadhesive layer 242. The distribution manifold 238 includes a fluiddistribution network 244 for providing a fluid to the microneedle array230. The fluid supplied from the distribution manifold 238 may be in theform of a liquid drug formulation. The membrane-draped microneedles 234are configured to penetrate a user's skin, such as for providing theliquid drug formulation into the user's skin by way of one or morepassageways or apertures 246 formed in each microneedle 234.

In the exemplary embodiment, the draped membrane 232 may be fabricatedfrom a polymeric (e.g., plastic) film, or the like, and coupled to themicroneedle array 230 using an additional adhesive layer 242. In otherembodiments, the draped membrane 232 may include an embossed ornano-imprinted, polymeric (e.g., plastic) film, or be fabricated from apolyether ether ketone (PEEK) film, or the draped membrane 232 may beany other suitable material, such as a polypropylene film. It iscontemplated that the microneedle array assembly 108 may not include thedraped membrane 232 in some embodiments.

In the exemplary embodiment, the microneedle array 230 may be fabricatedfrom a rigid, semi-rigid, or flexible sheet of material, for example,without limitation, a metal material, a ceramic material, a polymer(e.g., plastic) material, or any other suitable material that enablesthe microneedle array 230 to function as described herein. For example,in one suitable embodiment, the microneedle array 230 may be formed fromsilicon by way of reactive-ion etching, or in any other suitablefabrication technique.

As illustrated in FIG. 19A, the microneedle array 230 includes theplurality of microneedles 234 that extend outwardly from the backsurface 240 of the microneedle array 230. The microneedle array 230includes a plurality of passageways 246 extending between the backsurface 240 for permitting the fluid to flow therethrough. For example,in the exemplary embodiment, each passageway 246 extends through themicroneedle array 230 as well as through the microneedle 234.

Each microneedle 234 includes a base that extends downwardly from theback surface 240 and transitions to a piercing or needle-like shape(e.g., a conical or pyramidal shape or a cylindrical shape transitioningto a conical or pyramidal shape) having a tip 248 that is distal fromthe back surface 240. The tip 248 of each microneedle 234 is disposedfurthest away from the microneedle array 230 and defines the smallestdimension (e.g., diameter or cross-sectional width) of each microneedle234. Additionally, each microneedle 234 may generally define anysuitable length “L” between the base surface 236 of the microneedlearray 230 to its tip 248 that is sufficient to allow the microneedles234 to penetrate the user's skin, i.e., penetrate the stratum corneumand pass into the epidermis of a user. It may be desirable to limit thelength L of the microneedles 234 such that the microneedles 234 do notpenetrate through the inner surface of the epidermis and into thedermis, which may advantageously facilitate minimizing pain for theuser. In the exemplary embodiment, each microneedle 234 has a length Lof less than about 1000 micrometers (um), such as less than about 800um, or less than about 750 um, or less than about 500 um (e.g., anoverall length L ranging from about 200 um to about 400 um), or anyother subranges therebetween. The overall length L of the microneedles234 may vary depending on the location at which the fluid deliveryapparatus 10 is being used on the user. For example, and withoutlimitation, the overall length L of the microneedles 234 for a fluiddelivery apparatus to be used on a user's leg may differ substantiallyfrom the overall length L of the microneedles 234 for a fluid deliveryapparatus to be used on a user's arm. Each microneedle 234 may generallyhave any suitable aspect ratio (i.e., the length L over across-sectional width dimension D of each microneedle 234). The aspectratio may be greater than 2, such as greater than 3 or greater than 4.In instances in which the cross-sectional width dimension (e.g.,diameter) varies over the length of each microneedle 234, the aspectratio may be determined based on the average cross-sectional widthdimension.

The channels or passageways 246 of each microneedle 234 may be definedthrough the interior of the microneedles 234 such that each microneedleforms a hollow shaft, or may extend along an outer surface of themicroneedles to form a downstream pathway that enables the fluid to flowfrom the back surface 240 of the microneedle array 230 and through thepassageways 246, at which point the fluid may be delivered onto, into,and/or through the user's skin. The passageways 246 may be configured todefine any suitable cross-sectional shape, for example, withoutlimitation, a semi-circular or circular shape. Alternatively, eachpassageway 246 may define a non-circular shape, such as a “v” shape orany other suitable cross-sectional shape that enables the microneedles234 to function as described herein.

The microneedle array 230 may generally include any suitable number ofmicroneedles 234 extending from back surface 240. For example, in somesuitable embodiments, the quantity of microneedles 234 included withinthe microneedle array 230 is in the range between about 10 microneedlesper square centimeter (cm²) to about 1,500 microneedles per cm², such asfrom about 50 microneedles per cm² to about 1250 microneedles per cm²,or from about 100 microneedles per cm² to about 500 microneedles percm², or any other subranges therebetween.

The microneedles 234 may generally be arranged in a variety of differentpatterns. For example, in some suitable embodiments, the microneedles234 are spaced apart in a uniform manner, such as in a rectangular orsquare grid or in concentric circles. In such embodiments, the spacingof the microneedles 234 may generally depend on numerous factors,including, but not limited to, the length and width of the microneedles234, as well as the amount and type of liquid formulation that isintended to be delivered through or along the microneedles 234.

Furthermore, in the exemplary embodiment, the fluid distribution network244 includes, for example, a plurality of channels and/or aperturesextending between a top surface 250 and a bottom surface 252 of thedistribution manifold 238. The channels and/or apertures include acentrally-located inlet channel 254 coupled in flow communication with aplurality of supply channels 256 and the slot 224 formed in the thirdadhesive layer 200 of the plenum cap assembly 106 (shown in FIG. 14). Inthe exemplary embodiment, the supply channels 256 facilitatedistributing a fluid supplied by the inlet channel 254 across an area ofthe distribution manifold 238. Each of the supply channels 256 iscoupled in flow communication to a plurality of resistance channels (notshown). The resistance channels extend away from the supply channels 256and are formed to facilitate an increase in the resistance of the fluiddistribution network 244 to the flow of the fluid. Each resistancechannel is coupled in flow communication to an outlet channel 258. Asillustrated in FIG. 19A, each outlet channel 258 is aligned with arespective microneedle 234 for distributing the fluid through themicroneedle passageways 246. In other embodiments, the resistancechannel and channels 254, 256, and 258 may be formed in anyconfiguration that enables the distribution manifold 238 to function asdescribed herein.

In the exemplary embodiment, the distribution manifold 238 is formed bybonding a base substrate 260 including the inlet channel 254 formedthrough the substrate, and the supply channels 256 and the resistancechannels formed in a bottom surface 264, to a cover substrate 262including the outlet channels 258 formed therethrough. The inlet channel254 may be formed in the substrate 260 by drilling, cutting, etching,and or any other manufacturing technique for forming a channel oraperture through substrate 260. In the exemplary embodiment, the supplychannels 256 and the resistance channels are formed in the bottomsurface 264 of the substrate 260 using an etching technique. Forexample, in one suitable embodiment, wet etching, or hydrofluoric acidetching, is used to form the supply channels 256 and the resistancechannels. In another suitable embodiment, Deep Reactive Ion Etching(DRIE or plasma etching) may be used to create deep, high density, andhigh aspect ratio structures in substrate 260. Alternatively, the supplychannels 256 and resistance channels can be formed in bottom surface 264using any fabrication process that enables the distribution manifold 238to function as described herein. In the exemplary embodiment, the outletchannels 258 are formed through the cover substrate 262 by drilling,cutting, etching, and or any other manufacturing technique for forming achannel or aperture through substrate 262.

In the exemplary embodiment, the base substrate 260 and the coversubstrate 262 are bonded together in face-to-face contact to seal theedges of the supply channels 256 and the resistance channels of thedistribution manifold 238. In one suitable embodiment, direct bonding,or direct aligned bonding, is used by creating a prebond between the twosubstrates 260, 262. The prebond can include applying a bonding agent tothe bottom surface 264 of the substrate 260 and a top surface 266 of thecover substrate 262 before bringing the two substrates into directcontact. The two substrates 260, 262 are aligned and brought intoface-to-face contact and annealed at an elevated temperature. In anothersuitable embodiment, anodic bonding is used to form the distributionmanifold 238. For example, an electrical field is applied across thebond interface at surfaces 264 and 266, while the substrates 260, 262are heated. In an alternative embodiment, the two substrates 260, 262may be bonded together by using a laser-assisted bonding process,including applying localized heating to the substrates 260, 262 to bondthem together.

In the exemplary embodiment, the base substrate 260 and the coversubstrate 262 are fabricated from a glass material. Alternatively, thebase substrate 260 and the cover substrate 262 may be fabricated fromsilicon. It is contemplated that the base substrate 260 and the coversubstrate 262 may be fabricated from different materials, for example,substrate 260 may be fabricated from a glass and the substrate 262 mayfabricated from silicon. In other embodiments, the base substrate 260and the cover substrate 262 may be fabricated from any material andmaterial combination that enables the distribution manifold 238 tofunction as described herein.

FIG. 19B is a schematic cross-sectional view of an alternativeembodiment of the microneedle array assembly 108. In the exemplaryembodiment, the microneedle array assembly 108 includes a protectivecover 268 coupled to the microneedle array assembly 108 via an adhesive267. The adhesive 267 may be attached to a periphery of the protectivecover 268 to facilitate securing the protective cover 268 to themicroneedle array assembly 108, and in particular, to the microneedlearray 230. Alternatively, the adhesive layer 242 used to couple thedraped membrane 232 to the microneedle array 230 may extend outwardtoward a periphery of the microneedle array 230 and may be used toattach the protective cover 268 to the microneedle array assembly 108.In the exemplary embodiment, the protective cover 268 may be fabricatedfrom a material that is substantially impermeable to fluids, such as,for example, polymers, metal foils, and the like. The adhesive 267 maybe a pressure-sensitive adhesive that includes, for example,solvent-based acrylic adhesives, solvent-based rubber adhesives,silicone adhesives, and the like as is known in the art. While theprotective cover 268 is illustrated as a planar cover having a flangedperipheral sidewall, it is understood that it the protective cover 268may be a flexible sheet material, such as a laminate. The protectivecover 268 also includes at least one tab 269 that extends from an edgeof the protective cover 268 beyond the adhesive 267 to facilitateremoving (e.g., peeling) the protective cover away from the microneedlearray assembly 108.

FIG. 20 is a sectional view of the cartridge assembly 18 of the fluiddelivery apparatus 10 shown in FIG. 1A. FIG. 21 is an exploded,schematic of the cartridge assembly 18. In the exemplary embodiment, thecartridge assembly 18 includes a reservoir component 270 formedgenerally concentric about the central axis “A.” The reservoir component270 includes an upper cavity 272 and an opposing lower cavity 274coupled together in flow communication via a fluid passage 276. In theexemplary embodiment, the upper cavity 272 has a generally concavecross-sectional shape, defined by a generally concave body portion 278of the reservoir component 270. The lower cavity 274 has a generallyrectangular cross-sectional shape, defined by a lower wall 275 thatextends generally vertically downward from a central portion of theconcave body portion 278. An upper portion of the end of the fluidpassage 276 is open at the lowest point of the upper cavity 272, and anopposite lower portion of the fluid passage 276 is open at a centralportion of the lower cavity 274. The lower portion of the fluid passage276 expands outward at the lower cavity 274, forming a generally inversefunnel cross-sectional shape. In other embodiments, the cross-sectionalshapes of the upper cavity 272, the lower cavity 274, and the fluidpassage 276 may be formed in any configuration that enables thereservoir component 270 to function as describe herein.

The cartridge assembly 18 also includes an upper sealing member 280 (ormembrane) configured to couple to the reservoir component 270 and closethe upper cavity 272. The upper sealing member 280 is formed as anannular sealing membrane and includes a peripheral ridge member 282 tofacilitate sealingly securing the upper sealing member 280 to thecartridge assembly 18. A cartridge housing 284 extends over the uppersealing member 280 and is configured to fixedly engage the reservoircomponent 270. This facilitates securing the upper sealing member 280 insealing contact with the reservoir component 270, thereby closing theupper cavity 272.

In the exemplary embodiment, the cartridge housing 284 includes aannular, vertically-extending wall 286 that has an inward extendingflange member 288 configured to couple to the peripheral ridge member282 of the upper sealing member 280. In particular, the flange member288 cooperates with the concave body portion 278 of the reservoircomponent 270 to compress and sealingly secure the upper sealing member280 therebetween. In the exemplary embodiment, a lower end 300 of thevertically-extending wall 286 is coupled to a flange 302 of thereservoir component 270 via welding, for example, and withoutlimitation, ultrasonic welding, spin welding, laser welding, and/or heatstaking. In other embodiments, the vertically-extending wall 286 may becoupled to a flange 302 using any connection technique that enables thecartridge housing 284 to fixedly engage the reservoir component 270, forexample, and without limitation, via an adhesive bond and the like.

The cartridge housing 284 also includes an upper groove 304 and a lowergroove 306 formed circumferentially in an outer surface 308 of thevertically-extending wall 286. The upper and lower grooves 304, 306 aresized and shaped to engage the plurality of flexible tabs 116 of thesleeve component 100, and, in particular, the radially inward extendingprotrusions 122 formed at the free second end 120 of the plurality offlexible tabs 116, as is described herein. In addition, the cartridgehousing 284 also includes a plurality of latch receiving openings 310formed on an upper edge portion 312 of the vertically-extending wall286. The latch receiving openings 310 are configured to couple to themechanical controller assembly 20 to secure it to the cartridge assembly18, as described herein.

FIG. 22 is a sectional view of the cap assembly 320 of the fluiddelivery apparatus 10 shown in FIG. 1A. In the exemplary embodiment, thecap assembly 320 includes a septum component 322 and a snap capcomponent 324 coupled together. The septum component 322 is configuredto couple to the reservoir component 270 and close the lower cavity 274.The septum component 322 has a lower wall 326 that extends substantiallyperpendicular to the central axis “A.” The lower wall 326 includes aperipheral channel 328 that is configured to sealingly engage a rim 330of the lower wall 275 of the reservoir component 270. The septumcomponent 322 also includes an annular upper seal wall 332, transverseto the lower wall 326, and that extends axially into the lower cavity274 when coupled to the reservoir component 270. The snap cap component324 extends over the septum component 322 and is configured to fixedlyengage the lower wall 275 of the reservoir component 270. Thisfacilitates securing the septum component 322 in sealing contact withthe reservoir component 270, thereby sealingly closing the lower cavity274.

The snap cap component 324 includes a lower wall 334 that has a centralopening 336 to facilitate access to the lower wall 326 of the septumcomponent 322 during use of the fluid delivery apparatus 10. The snapcap component 324 includes an annular vertically-extending wall 338 thatextends upwardly and downwardly from a periphery of the lower wall 334.In the exemplary embodiment, an upper portion 340 of thevertically-extending wall 338 engages the lower wall 275 of thereservoir component 270 via a latching component 342. The latchingcomponent 342 includes an inwardly projecting flange for connecting withan opposing groove 344 formed in the lower wall 275 of the reservoircomponent 270. It is contemplated that the latching component 342 can bea continuous annular flange or may include a plurality of inwardlyprojecting flange components. In other embodiments, thevertically-extending wall 338 may engage the lower wall 275 of thereservoir component 270 using any connection technique that enables thesnap cap component 324 to fixedly engage the lower wall 275, forexample, and without limitation, via an interference fit, an adhesivebond, a weld joint (e.g., spin welding, ultrasonic welding, laserwelding, or heat staking), and the like. In the exemplary embodiment, alower portion 346 of the vertically-extending wall 275 includes anoutwardly extending flange portion 348 that defines a peripheral sealingsurface 350 configured to engage an additional seal member (not shown)that extends between the snap cap component 324 and the upper rim 168 ofthe annular central wall 166 of the plenum component 102.

FIG. 23 is an exploded, perspective view of the mechanical controllerassembly 20 of the fluid delivery apparatus 10 shown in FIG. 1A. In theexemplary embodiment, the mechanical controller assembly 20 includes atleast a body component 360, a plunger component 362, and a biasingassembly 364 positioned between the body component 360 and the plungercomponent 362 for biasing the plunger component 362 in an axialdirection away from the body component 360. The body component 360includes a pair of retention plates 366 configured to couple a pair ofpivoting latches 368 to the body component 360, and a threadedadjustment member 370 configured to adjust an amount of force applied bythe biasing assembly 364 to the plunger component 362.

FIG. 24 is a perspective view of the body component 360. FIG. 25 is atop view of the body component 360. FIG. 26 is a sectional view of thebody component 360 taken about line 26-26 of FIG. 25. FIG. 27 is asectional view of the body component 360 taken about line 27-27 of FIG.25. In the exemplary embodiment, the body component 360 includes agenerally disk-shaped outer body portion 390 and a generallycylindrical-shaped inner portion 392 extending upward from the outerbody portion 390. The body component 360 is formed generallysymmetrically about lines 26-26 and 27-27 as illustrated in the figures.The outer body portion 390 includes a transversely extending top wall394 and an annular sidewall 396 depending from the top wall 394. The topwall 394 has a cavity 398 defined therein with a smaller centralaperture 400 extending therethrough. In the exemplary embodiment, thecavity 398 and the aperture 400 are generally rectangular in shape.Alternatively, the cavity 398 and the aperture 400 can be any shape thatenables the body component 360 to function as described herein. In theexemplary embodiment, the cavity 398 has a plurality of notches 402defined therein for receiving the pivoting latches 368. In particular,the plurality of notches 402 includes two pairs and notches 402generally aligned across the central aperture 400 and positionedgenerally symmetrically about line 26-26. As illustrated in FIGS. 24 and27, the notches 402 extend downwardly into a bottom wall 404 of thecavity 398.

The top wall 394 includes a plurality of openings 406 definedtherethrough and configured to receive a latch component of a respectiveretention plate 366. Positioned on either side of a respective opening406 are threaded holes 408. The threaded holes 408 receive mechanicalhardware 410 used to couple the retention plates 366 to the bodycomponent 360. As illustrated in FIGS. 24 and 26, the annular sidewall396 includes cutouts 412 proximate each opening 406 to enable the latchcomponents of the retention plates 366 to extend thereby, as describedfurther herein.

In the exemplary embodiment, the cylindrical-shaped inner portion 392includes an annular wall 414 that extends upwardly from the bottom wall404 of the cavity 398, as best illustrated in FIGS. 24 and 26. Inaddition, as illustrated in FIGS. 24 and 27, the annular wall 414 has abottom edge 416 over the central aperture 400 that is located apredetermined distance 418 above the top wall 394. Accordingly, a spaceis defined between the bottom wall 404 of the cavity 398 and the bottomedge 416 of the annular wall 414 to enable the pivoting latches 368 toengage the plunger component 362 as is described further herein.

The cylindrical-shaped inner portion 392 further includes a plurality ofgusset portions 418 that extend from top wall 394 to a top edge 420 ofannular wall 414. In particular, the body component 360 includes twosymmetrically oriented gusset portions 418 that extend radially outwardfrom annular wall 414 through the cavity 398 and into the top wall 394.In addition, the gusset portions 418 extend upwardly and taper radiallyinwardly from the top wall 394 to the top edge 420 of the annular wall414. The gusset portions 418 are configured to provide additionalstructural support to the cylindrical-shaped inner portion 392 of thebody component 360. Furthermore, as illustrated in FIG. 27, the annularwall 414 has a predetermined length 422 from the top edge 420 to thepredetermined distance 418 above the top wall 394. The annular wall 414includes a threaded portion 424 defined therein that extends downwardlyfrom the top edge 420 a distance 426, where the distance 426 is lessthan the length 422 of the annular wall 414. This enables the threadedadjustment member 370 to be coupled to the body component 360, withoutbeing able to be threaded entirely through the cylindrical-shaped innerportion 392.

FIG. 28 is a perspective view of a pivoting latch 368 of the mechanicalcontroller assembly 20. In the exemplary embodiment, the pivoting latch368 is formed generally symmetrically about an X-Y plane defined by theaxes 460. The pivoting latch 368 includes an elongated lever portion 450that has a pair of cylindrical pins 452 coupled to an end portion 454 ofthe lever portion 450. A respective cylindrical pin 452 extends fromeach side of the lever portion 450 such that the cylindrical pins 452are coaxial about a centerline “B.” A latch portion 456 extends awayfrom the lever portion 450 at the end portion 454. In particular, thelatch portion 456 extends from the end portion 454 of the lever portion450 at an angle σ with respect to the lever portion 450. The latchportion 456 includes a concave cutout 458 that extends through the latchportion 456. More specifically, the concave cutout 458 is defined by aradius “R” about a centerline “C.” Centerline “C” is in the X-Y plane ofthe axes 460 and is inclined at the same angle σ as the latch portion456 is with respect to the lever portion 450. As such, the concavecutout 458 extends through the latch portion 456 at angle σ, where thecenterline “C” of the concave cutout 458 is substantially perpendicularto the lever portion 450.

FIG. 29 is a front perspective view of a retention plate 366 of themechanical controller assembly 20. FIG. 30 is a rear perspective view ofthe retention plate 366. In the exemplary embodiment, the retentionplate 366 is generally symmetrical about a centerline “D,” and includesa generally rectangular-shaped body portion 462. A front or outer edge464 of the body portion 462 has a radius that is substantially similarto a periphery of the body component 360. A pair of countersink holes466 are formed through the body portion 462 and are configured toreceive the mechanical hardware 410, as is described herein. Eachcountersink hole 466 includes an elongated slot 468 formed therethroughand generally parallel to the centerline “D.” The slots 468 enable theretention plate 366 to slide radially with respect to the central axis“A” of the body component 360 when coupled thereto. The body portion 462also includes an elongated open-ended slot 470 extending therethroughand generally centered on the centerline “D.” The open-ended slot 470 isconfigured to receive at least a portion of a respective gusset portion418 of the body component 360 when coupled thereto.

Extending downwardly from the bottom of the body portion 462 is a pairof bosses 472; one positioned on each side of the open-ended slot 470and adjacent a rear edge 474 of the retention plate 366. The bosses 472are configured to facilitate coupling the pivoting latches 368 to thebody component 360. In particular, the bosses 472 are sized and shapedto extend into the cavity 398 in generally face-to-face contact with thebottom wall 404, and to extend across a width of the notches 402 formedin the cavity 398 of the body component 360, i.e., a respective boss 472extends across a top opening of a respective notch 402. As describedfurther herein, the cylindrical pins 452 of the pivoting latches 368 arepositioned into the notches 402 when the fluid delivery apparatus 10 isassembled, and as described, are retained within the notches 402 by thebosses 472 of the retention plates 366.

Each retention plate 366 also includes a latch component 476 thatextends downwardly from the bottom of the body portion 462 adjacent theouter edge 464. The latch component 476 is positioned such that it isgenerally centered about the centerline “D.” The latch component 476 hasan elongate body portion 478 formed integrally with the body portion 462of the retention plate 366. The free end of the latch component 476includes an outward extending protrusion 480 configured to provide areleasable latching connection with the latch receiving openings 310 ofthe cartridge housing 284 of the cartridge assembly 18.

FIG. 31 is a perspective section view of the assembled mechanicalcontroller assembly 20, FIG. 32 is a top view of the mechanicalcontroller assembly 20, FIG. 33 is a sectional view of the mechanicalcontroller assembly 20 taken about line 33-33 of FIG. 32, and FIG. 34 isa sectional view of the mechanical controller assembly 20 taken aboutline 34-34 of FIG. 32. With reference to the FIGS. 23 and 31-34, thebiasing assembly 364 includes a first biasing member 372 and a secondbiasing member 378. In one embodiment, first biasing member 372 and asecond biasing member 378 are springs. Alternatively, first biasingmember 372 and a second biasing member 378 include any biasing componentthat enables biasing assembly 364 to function as described herein,including, for example, elastic, resilient materials; foams; fluid(i.e., gas or liquid) compression members, and the like. In theexemplary embodiment, the first biasing member 372 and the secondbiasing member 378 each have a different length and a different forceconstant (or force profile). The biasing assembly 364 also includes athreaded fastener 374, a tube 376, an insert component 380, and a nut382 configured to couple to the threaded fastener 374.

The insert component 380, as best illustrated in FIGS. 23 and 35, isgenerally cylindrically shaped and is symmetrical about the central axis“A.” The insert component 380 includes a body 482 that has a cylindricalprotrusion 484 extending from a first end 486 of the body 482. A secondend 488 of the body 482 includes a first bore 490 that is sized toreceive an end of the first biasing member 372 therein. The body 482also includes a second bore 492 that is smaller than the first bore 490and is sized to receive an end of the second biasing member 378 therein.An aperture 494 extends through the insert component 380 and is sized toreceive the tube 376 therethrough.

As illustrated in the FIGS. 23 and 31-34, the threaded fastener 374 isinserted through the tube 376. The second biasing member 378 ispositioned about the tube 376 such that an end of the second biasingmember 378 rests on a head 384 of the threaded fastener 374. As such,the second biasing member 378 has as inner diameter that is larger thanthe periphery of the tube 376 and smaller than the periphery of the head384 of the threaded fastener 374. The threaded fastener 374 and the tube376 are inserted through the aperture 494 of the insert component 380from the second end 488 such that the second biasing member 378 isseated in the second bore 492 of the insert component 380. The nut 382is coupled to the threaded fastener 374 to facilitate retaining theinsert component 380 on the threaded fastener 374 and the tube 376.

In the exemplary embodiment, the threaded adjustment member 370 iscoupled to the threaded portion 424 of the cylindrical-shaped innerportion 392 of body component 360 to facilitate positioning the insertcomponent 380 axially within the cylindrical-shaped inner portion 392.As described herein, this enables an amount of force applied by thebiasing assembly 364 to the plunger component 362 to be adjusted. In theexemplary embodiment, the insert component 380, with the threadedfastener 374, the tube 376, the second biasing member 378, and the nut382 coupled thereto, is inserted into the cylindrical-shaped innerportion 392 such that it is in contact with the threaded adjustmentmember 370.

The pivoting latches 368 are positioned in the body component 360 suchthat the cylindrical pins 452 are located in the notches 402 and thelatch portions 456 extend radially inward. The retention plates 366 arepositioned on the body component 360 with each respective latchcomponent 476 extending downwardly through a respective opening 406. Thebosses 472 of each respective retention plate extend over the notches402, thereby retaining the cylindrical pins 452 of the pivoting latches368 therein. This enables the pivoting latches 368 to rotate about thecylindrical pins 452, but to remain coupled to the body component 360.The retention plates are coupled to the body component 360 via themechanical hardware 410 threadably coupled to the threaded holes 408 ofthe body component 360.

As illustrated in the FIGS. 31, 33, and 34, the first biasing member 372positioned in the first bore 490 of the insert component 380. In theexemplary embodiment, the first biasing member 372 has an inner diameterthat is larger than the periphery of the second biasing member 378 andthe head 384 of the threaded fastener 374. The first biasing member 372extends from the first bore 490 of the insert component 380 to theplunger component 362. The plunger component 362 includes a disk-shapeddomed head 386 with an annular guide wall 387 coaxially extendingvertically-upward from the domed head 386. As illustrated, the guidewall 387 is configured to receive the first biasing member 372 and thesecond biasing member 378 therein. The guide wall 387 includes anoutwardly extending flange 388 adjacent the free end of the guide wall387. The flange 388 is configured to engage the pivoting latches 368,and in particular, the latch portions 456, to facilitate retaining theplunger component 362 in a pre-use configuration, as shown in the FIGS.33 and 34. In the exemplary embodiment, the domed head 386 is configuredto engage the upper sealing member 280 of the cartridge assembly 18 viaforce applied by the biasing assembly 364 during use of the fluiddelivery apparatus 10.

In the exemplary embodiment, with reference to the figures, in onesuitable embodiment, the fluid distribution assembly 14 of the fluiddelivery apparatus 10 is assembled by coupling the cap assembly 320 tothe cartridge assembly 18. In particular, the upper seal wall 332 of theseptum component 322 is inserted into the lower cavity 274 of thereservoir component 270 and the latching component 342 of the snap capcomponent 324 is snapped into the groove 344 of the reservoir component270. As such, the snap cap assembly 320, and in particular, the septumcomponent 322 seals the fluid passage 276 of the upper cavity 272 of thecartridge assembly 18. A fluid may be disposed into the upper cavity 272for delivery to a user during use of the fluid delivery apparatus 10.The upper cavity 272 is closed by the upper sealing member 280, which issecured by the cartridge housing 284.

The mechanical controller assembly 20 is assembled in the pre-useconfiguration, as shown in the FIGS. 33 and 34, and is coupled to theupper portion of the cartridge assembly 18 via the retention plates 366.In particular, the annular sidewall 396 of the body component 360 ispositioned on the upper edge portion 312 of the cartridge housing 284such that the cutouts 412 in the annular sidewall 396 are aligned withthe latch receiving openings 310 of the cartridge housing 284. Themechanical hardware 410 is loosened to enable the retention plates 366to be displaced radially about the centerline “E,” and enable the latchcomponents 476 to engage the latch receiving openings 310. Themechanical hardware 410 is then tightened to secure the mechanicalcontroller assembly 20 to the cartridge assembly 18.

In the exemplary embodiment, the cartridge assembly 18, along with theattached cap assembly 320 and the mechanical controller assembly 20, iscoupled to the plenum assembly 16. As described herein, the plenumassembly 16 includes the plenum cap assembly 106 and the microneedlearray assembly 108 coupled thereto. The cartridge assembly 18 isinserted into the cavity 110 of the plenum assembly 16. The flexibletabs 116 flex radially outwardly to receive the cartridge assembly 18therebetween. The annular lower groove 306 of the cartridge housing 284is aligned with the radially inward extending protrusions 122 of theflexible tabs 116, which enables the flexible tabs 116 to flex radiallyinward to secure the cartridge assembly 18 in the pre-use configuration.

In the exemplary embodiment, the fluid distribution assembly 14 of thefluid delivery apparatus 10 is coupled to the collet assembly 12 with byinserting the fluid distribution assembly 14 axially into the hollowinterior space 24 of the collet assembly 12 from below. In particular,the recesses 130 of the sleeve component 100 of the plenum assembly 16are axially aligned to the tabs 74 of the collet lock 50. The fluiddistribution assembly 14 is displaced axially upwardly until top surface142 of the lower wall portion 112 of the sleeve component 100 contactsthe flexible tabs 48 of the collet assembly 12. The fluid distributionassembly 14 is rotated about the central axis “A” to axially align theflexible tabs 48 to the recesses 130. This facilitates displacing thetabs 74 of the collet lock 50 circumferentially into the recesses 132 ofthe sleeve component 100. The fluid distribution assembly 14 is againdisplaced axially upwardly, the displacement being stopped in responseto the top surface 142 of the lower wall portion 112 of the sleevecomponent 100 contacting the inner horizontal surface 42 of the step 38of the collet 22. As such, the fluid distribution assembly 14 is axiallypositioned above the tabs 74 of the collet lock 50. The fluiddistribution assembly 14 is then rotated about the central axis “A” toaxially align the recesses 128 of the sleeve component 100 with the tabs74. As the fluid distribution assembly 14 is rotated, the flexible tabs48 slide along the planar portion of the recesses 130 that overhangs therecesses 132. This causes the flexible tabs 48 to flex radiallyoutwardly. As the fluid distribution assembly 14 is rotated, theflexible tabs 48 rotationally engage the outer surface 150 of the stops146 and flex radially inwardly against the outer surface 150 to providea snap-fit connection between the fluid distribution assembly 14 and thecollet assembly 12. This facilitates preventing additional rotation offluid distribution assembly 14 with respect to the collet assembly 12and positions the recesses 128 into axial alignment with the tabs 74.The fluid delivery apparatus 10 is thereby assembled in the pre-useconfiguration shown in FIG. 1A.

In one suitable embodiment, the fluid delivery apparatus 10 includes theattachment band 430, such as, for example, and without limitation, anarm band, a leg band, a waist band, wrist band, and the like. Theattachment band 430 is configured to couple to the collet assembly 12 tofacilitate attaching the fluid delivery apparatus 10 to a user duringuse. FIG. 36 is a perspective view of the attachment band 430 of thefluid delivery apparatus 10 of FIG. 1A, and FIG. 37 is an enlarged sidesectional view of the attachment band 430 assembled to the colletassembly 12. In the exemplary embodiment, the attachment band 430includes an annular body 432 having a wall 434 that is formed in agenerally frustoconical shape, having a hollow inner space 435 definedtherein. The annular body 432 is sized and shaped to correspond to theupper wall 30 and the lower wall 34 the collet 22. The inner space 435is configured for receiving the fluid delivery apparatus 10. Theattachment band 430 includes an inner step 436 that extendscircumferentially around an inner surface 438 of the wall 434 of theannular body 432. In the exemplary embodiment, the inner step 436corresponds to the step 38 and the horizontal surface 40 that extendsaround the upper wall 30 of the collet 22.

As illustrated in FIG. 36, the attachment band 430 includes an adjacentpair of attachment apertures 440 configured to couple to the secondcoupling members 68 of the collet lock 50, respectively. In particular,the apertures are sized and shaped to correspond to the neck portion 67,such that the head portion 69 retains the attachment band 430 on thecollet assembly 12. In addition, the attachment band 430 includes anindicator aperture 442 opposite the attachment apertures 440. Theindicator aperture 442 is generally kidney-shaped, whereas it is sizedand shaped to correspond to the neck portion 63 of the first couplingmember 66, such that the head portion 65 retains the attachment band 430on the collet assembly 12. The indicator aperture 442 has an innerextension portion 444, or an indicator or an indicator portion, thatextends inwardly from an edge of the indicator aperture 442. Inparticular, the indicator 444 is a tab that extends generally upwardalong wall 434 from a lower edge of indicator aperture 442. Theindicator 444 is configured to extend into the window 61 of the headportion 65 and is configured to present an indication to the user of thefluid delivery apparatus 10 of a tightness of the attachment band 430.

The attachment band 430 includes a first strap 446 that extendsgenerally radially outward from the annular body 432. In the exemplaryembodiment, the first strap 446 is substantially aligned radially withthe attachment apertures 440. The attachment band 430 also includes anopposite second strap 448 that extends generally radially outward fromthe annular body 432 and is substantially aligned radially with theindicator aperture 442. In the exemplary embodiment, the straps 446, 448have a width that is less than a diameter of the annular body 432.Alternatively, the straps 446, 448 can have any width that enables theattachment band 430 to function as described herein. Additionally, inthe exemplary embodiment, the annular body 432 and the straps 446, 448are fabricated as an integral component. For example and withoutlimitation, in one suitable embodiment, the annular body 432 and thestraps 446, 448 may be fabricated from a resilient material, such as athin elastomer. Alternatively, the annular body 432 and the straps 446,448 may be fabricated separately and assembled using any fasteningmethod that enables the attachment band 430 to function as describedherein, for example, and without limitation, the straps 446, 448 can becoupled to the annular body 432 using spring pins or hinges.

As illustrated in FIG. 36, the second strap 448 includes at least oneretaining aperture 496. In the exemplary embodiment, the retainingapertures 496 are fabricated from a rigid material, for example, andwithout limitation, a rigid plastic and/or metal. The retaining aperture496 can be insert molded into second strap 448 or coupled thereto, forexample, and without limitation, via adhesive bonding and/or mechanicalcoupling. In the exemplary embodiment, the first strap 446 and thesecond strap 448 are configured to couple to each other to secure thefluid delivery apparatus 10 to the users. For example, the second strap448 includes two adjacent retaining apertures 496, and the first strap446 may be wrapped around a portion of the user (e.g., a wrist, an arm,a leg, etc.) and then fed through one of the retaining apertures 496 andfolded back and extended through the second retaining aperture 496.Alternatively, the attachment band 430 may include one retainingaperture 496, and the first strap 446 may have a length of hook and loopmaterial (not shown) coupled arranged thereon. The first strap 446 maythen be fed through the retaining aperture 496 and folded back uponitself so as to fasten with the loop fastening element to the hookfastening element. In other embodiments, the straps 446, 448 can haveany coupling mechanism that enables the fluid delivery apparatus 10 tofunction as described herein.

FIG. 38 is an enlarged perspective view of the attachment band 430coupled to the collet assembly 12, illustrating a first orientation ofthe indicator 444 in a pre-use configuration. FIG. 39 is an enlargedperspective view of the attachment band 430 coupled to the colletassembly 12, illustrating a second orientation of the indicator 444 in ause configuration. The fluid distribution assembly 14 is not shown inFIGS. 38 and 39. In the exemplary embodiment, the straps 446, 448 areuncoupled or loose in the pre-use configuration of the fluid deliveryapparatus 10. The indicator 444 is visible through the window 61 formedin the head portion 65 of the first coupling member 66, however, becausethe second strap 448 is free of tension, the edge of the indicator 444is located at the top of the window 61. The indicator 444 thus providesa visual indication of the lack of tension in the attachment band 430 tothe user via the window 61. During use, the straps 446, 448 are coupledtogether and tension is applied. Thus, as illustrated in FIG. 39, theedge of the indicator 444 moves downwardly in the window 61 due to thetension in the resilient material of the second strap 448. The indicator444 thus provides a visual indication of an amount of tension in theattachment band 430 to the user via the window 61. It is contemplatedthat the head portion 65 of the first coupling member 66 may contain avisual reference to indicate to the user an appropriate amount oftension in the attachment band 430. For example, and without limitation,the head portion 65 can include a mark than aligns with the edge of theindicator 444 when the appropriate amount of tension is achieved in theattachment band 430.

As illustrated in FIGS. 37-39, the attachment band 430 is coupled to thecollet assembly 12 via the apertures 440, 442. The fluid deliveryapparatus 10 is positioned in the inner space 435. The attachmentapertures 440 are expanded to receive a respective coupling member 68.The resilient material of the attachment band 430 enables each aperture440 to expand such that the head portion 69 of the coupling member 68can be displaced therethrough. After displacing the head portion 69through the aperture 440, the aperture 440 returns to its original shapeand size due to the resiliency of the material used to fabricate theattachment band 430. As such, the attachment apertures 440 encircle theneck portion 67 of the coupling members 68 such that the head portions69 cannot be easily displaced back through the attachment apertures 440.Similarly, the indicator aperture 442 is expanded to receive the firstcoupling member 66. The indicator aperture 442 is expanded to enable thehead portion 65 to be displaced through the indicator aperture 442. Theindicator aperture 442 returns to its original size and shape toencircle the neck portion 63 such that the head portion 65 cannot beeasily displaced back through the indicator aperture 442.

To further secure the fluid delivery apparatus 10 to the attachment band430 and to enable the attachment band 430 to apply a generally axialforce to the fluid delivery apparatus 10, the inner step 436 of theattachment band 430 to positioned against the step 38 of the colletassembly 12. In addition, the inner surface 438 of the attachment band430 in positioned against the upper wall 30 of the collet assembly 12.The band is secured in place via the apertures 440, 442, and thecoupling members 66, 68. When the attachment band 430 is tightenedaround the user's body, such as an arm or wrist of the user, the bandprovides a substantially axial force to the fluid delivery apparatus 10,generally along the central axis “A.” The axial force against the user'sbody facilitates deforming the user's skin, for example, by pushing orcrowning a portion of the user's skin encircled by the collet assembly12. The indicator 444, which is visible through the window 61 of thefirst coupling member 66, presents a visual indication to the user thatindicates a proper amount of force is applied to the fluid deliveryapparatus 10. The skin deformation and the crowning of the portion ofthe user's skin encircled by the collet assembly 12 facilitate properpenetration of the microneedle array assembly 108 into the user's skin.

An applicator 500 (or broadly an application device) is provided tofacilitate the transition of the fluid delivery apparatus 10 from thepre-use configuration shown in FIG. 1A to the pre-activatedconfiguration shown in FIG. 1B. FIG. 40 is a perspective view of onesuitable embodiment of the applicator 500 of the fluid deliveryapparatus 10. FIG. 41 is a front sectional view of the applicator 500.FIG. 42 is a side sectional view of the applicator 500. FIG. 43 is a topsectional view of the applicator 500, taken about line 43-43 shown inFIG. 40. In the exemplary embodiment, the applicator 500 has a housing502 with a button 504 (or release) for activating the applicator 500.The housing 502 encloses a piston 506 (or impact component) used toactivate the fluid delivery apparatus 10. The piston is locked into asafety position by one or more safety arms 508, 509. In addition, thehousing encloses safety arm springs 510, piston spring 512, and buttonspring 514.

In the exemplary embodiment, the elongate body 520 has a generallycylindrical shape tapering inwardly from a bottom 516 to a top 518 ofthe body 520. The housing 502 also includes a cap 522 coupled to the top518 of the body 520. The cap 522 is configured to retain the button 504,which is configured to move axially with respect to the body 520. It isnoted that the applicator 500 is formed substantially symmetrical aboutan X-Y plane and a Y-Z plane that includes the centerline “E,” as shownin FIG. 40.

With reference to the FIGS. 41-43, the body 520 includes a stepped bore528 that extends through the body 520. At the bottom end 516, thestepped bore 528 includes a first step portion 530 that has a peripherythat is sized and shaped to receive the upper wall 30 of the collet 22therein. As shown in FIG. 41, the first step portion 530 extendsupwardly from the bottom 516 of the body 520 a predetermined distance532. The stepped bore 528 also includes a second step portion 534 thatextends upwardly from the first step portion 530 a predetermineddistance 536. In the exemplary embodiment, the second step portion 534has a periphery that is sized and shaped to receive the fluiddistribution assembly 14 while the first step portion 530 is in contactwith the upper wall 30 of the collet 22. In addition, the stepped bore528 includes a third step portion 538 that extends upwardly from thesecond step portion 534 and continues through the body 520. Positionedinside the body 520, and in particular, the third step portion 538 is aretaining ring 525. The retaining ring 525 is configured facilitateretaining the piston 506 and the safety arms 508, 509 axially within thehousing 502. In addition, the third step portion 538 includes aplurality of axially-extending grooves 540 that extend upwardly from thesecond step portion 534 a predetermined distance 542. The grooves 540have a curved cross-sectional shape that is generally centered on aradially extending line from the centerline “E.” That is, the grooves540 extend axially through the second step portion 534 and are arrangedradially about the centerline “E.” Alternatively, the cross-sectionalshape of the grooves 540 can be any shape that enables the applicator500 to function as described herein. In the exemplary embodiment, thethird step portion 538 has a periphery that is sized and shaped toreceive the piston 506 therein.

In the exemplary embodiment, the third step portion 538 of the steppedbore 528 includes a piston retention member 546 that is positioned apredetermined distance 544 upwardly from the grooves 540. The pistonretention member 546 is formed from a body that extends radiallyinwardly from an outer wall 548 of the body 520 and is configured tofacilitate locking the piston 506 in place until the safety arms 508,509 are actuated, thereby unlocking the piston 506. In addition, thepiston retention member 546 functions as a spring seat for the pistonspring 512 that is positioned between the piston 506 and the pistonretention member 546, and the button spring 514 that is positionedbetween the button 504 and the piston retention member 546.

The body 520 also includes an opposing pair of longitudinal channels 550that extend axially through the body 520. The channels 550 extendthrough the second and third step portions 534, 538, respectively, ofthe stepped bore 528. As best illustrated in FIG. 41, the channels 550are formed in the wall 548 of the body 520 and taper outward at thebottom 516 from the third step portion 538 to the second step portion534. As such, the safety arms 508, 509 can be inserted into the channels550 such that they do not interfere with the fluid delivery apparatus 10during activation and/or use of the applicator 500. Thus, the channels550 are sized and shaped to receive a respective safety arm 508, 509slidingly therein, i.e., the safety arms 508, 509 are free to slideaxially within the body 520 during use of the applicator 500. As bestillustrated in FIG. 43, the grooves 540 and the channels 550 aregenerally circumferentially spaced equidistant about the centerline “E.”

FIG. 44 is a perspective view of the safety arm 508. In the exemplaryembodiment, the applicator includes two safety arms 508, 509.Alternatively, the applicator may include any number of safety arms thatenable the applicator 500 to function as described herein. It is notedthat in the exemplary embodiment, the safety arm 509 is formedsubstantially similar to safety arm 508, but as a symmetrical opposite.Thus, only the detailed description of safety arm 508 is providedherein. In the exemplary embodiment, the safety arm 508 includes anelongate body portion 552 that includes an upper end 554 and a lower end556. The body portion 552 has a cross-sectional shape that is generallyrectangular. Alternatively, the body portion can have anycross-sectional shape that enables the safety arm 508 to function asdescribed herein. In the exemplary embodiment, at the upper end 554, thesafety arm 508 includes a spring engagement member 562 that extendaxially along the elongate body portion 552. The spring engagementmember 562 is configured to engage the safety arm spring 510, whichbiases the safety arm 508 into the safety position within the applicator500.

Furthermore, the safety arm 508 includes a piston locking arm 558 thatextends generally perpendicular to the elongate body portion 552. Thepiston locking arm 558 includes a protrusion 560 extending therefrom. Asillustrated in FIG. 41, the locking arm 558 extends radially inward pasta portion of the piston retention member 546 to a positioned adjacentthe piston 506. The protrusion 560 extends forward from the locking arm558 and is configured to facilitate preventing the piston 506 fromreleasing from the piston retention member 546, as is described furtherherein.

At the lower end 556, the safety arm 508 includes a retention member 564that extends outwardly from an inner surface 566 of the elongate bodyportion 552. As illustrated in FIG. 41, the retention member 564 extendsradially inwardly with respect the applicator 500 and is configured tocontact the retaining ring 525 when the safety arm 508 is biased axiallyin the safety position. Thus, the retention member 564 facilitatesretaining the safety arm 508 within the applicator 500. The lower end556 of the elongate body portion 552 tapers generally outwardly oppositethe retention member 564, forming a notch 567. As illustrated in FIG.41, the notch 567 is configured to correspond to the second step portion534 of the stepped bore 528. As such, the safety arm 508 may bepositioned in the channel 550 of the housing 502 and retained for axialmovement therein.

FIG. 45 is a front perspective view of the piston 506 of the applicator500 shown in FIG. 40. In the exemplary embodiment, the piston 506includes a piston head 568 coupled to a piston hanger 570 via mechanicalhardware (not shown). The piston head 568 is a generally cylindricalsolid body that includes threaded holes (not shown) that correspond tomounting holes 578 formed in the piston hanger 570. The mounting holes578 and the threaded holes in the piston head 568 facilitate releasablycoupling the piston head 568 to the piston hanger 570. In the exemplaryembodiment, the piston head 568 is fabricated as a generally solidcomponent having a predetermined mass that enables the piston 506 toachieve a desirable velocity and impulse rate during use of theapplicator 500 to properly activate the fluid delivery apparatus 10 foruse.

The piston hanger 570 includes a generally annular bottom wall 572 thatincludes a plurality of axially extending protrusions 574. Each of theprotrusions 574 generally correspond to a respective groove 540 formedin the body 520 of the housing 502. The protrusions 574 have a generallycurved shape that is generally aligned with a radially extending linefrom the centerline “E.” That is, the protrusions 574 extend axiallyalong the bottom wall 572 and are arranged radially about the centerline“E.” Alternatively, the shape of the protrusions 574 can be any shapethat enables the piston hanger 570 to slidably engage the housing 502 asdescribed herein.

The piston hanger 570 also includes a pair of tapered arms 576 arrangedsubstantially symmetrically about the centerline “E.” The tapered arms576 extend upwardly from the bottom wall 572. As illustrated in theFIGS., the mounting holes 578 are positioned between the tapered arms576 and extend axially through the bottom wall 572. As illustrated inthe FIGS. 45-47, the piston hanger 570 includes a bridge portion 580that extends between upper ends 582 of the tapered arms 576. As such, aclosed longitudinal gap 584 is defined between the tapered arms 576, thebottom wall 572, and the bridge portion 580. The gap is sized to receivethe piston retention member 546 of the housing 502 slidingly therein.The bridge portion 580 includes an upper inclined face 586 that isconfigured to engage the button 504 of the applicator 500 to facilitaterelease of the piston 506 from the piston retention member 546, as isfurther described herein.

With reference the FIGS. 40-42, the button 504 includes a body portion590 that has a release member 592 extending generally axially downwardlytherefrom. The release member 592 includes an inclined face 594 that isconfigured to slidingly engage the upper inclined face 586 of the pistonhanger 570. The button also includes a cavity 596 that is configured toreceive at least a portion of the bridge portion 580 therein when thebutton 504 is actuated. A pair of opposite retention members 598 extendsgenerally radially outwardly from the bottom of the body portion 590. Asillustrated in FIG. 42, each retention member 598 is positioned in achannel defined in the housing 502. In particular, the body 520 includesa pair of channels 600 that correspond to a pair of channels 602 formedin the cap 522 to define a channel that retains the button 504 andfacilitates axial displacement of the button 502.

In the exemplary embodiment, the safety arms 508, 509 are inserted intothe housing 502 and positioned in the channels 550 such that the lowerend 556 is positioned at the second step portion 534 of the stepped bore528. In addition, the piston spring 512 is inserted into the steppedbore 528 and positioned against the bottom of the piston retentionmember 546. The piston 506 is positioned in the third step portion 538of the stepped bore 528. In particular, the protrusions 574 of thepiston 502 are each aligned with a respective groove 540 of the housing502. Further, the piston hanger 570 is inserted axially through thepiston spring 512 and oriented to engage the piston retention member546. The retaining ring 525 is coupled to the housing 502 to axiallyretain the piston 502 and the safety arms 508, 509 within the housing502. The safety arm springs 510 and the button spring 514 are insertedinto the stepped bore 528 from the top 518 of the body 520. The buttonspring 514 rests against the top of the piston retention member 546 andthe safety arm springs 510 rest against the top of the safety arms 508,509. The button 504 is positioned against the top 518 of the body 520with the retention members 598 aligned with the channels 600 defined inthe body 520. The cap 522 is coupled to the top 518 of the housing 502with one or more fasteners (not shown) to retain the button 504 and thesafety arm springs 510.

In operation, the piston 506 is displaced axially upwardly in thestepped bore 528. Clearance between the protrusions 574 of the piston502 and the grooves 540 of the housing 502 enable the bridge portion 580of the piston 506 to be displaced an amount off axis to slide axiallypast the piston retention member 546. The piston spring 512 functions tobias the piston 506 downwardly with respect to the piston retentionmember 546. This also facilitates generally aligning the axis of thepiston 506 with the axis of the housing 502 to enable the bridge portion580 to engage the piston retention member 546. As such, the pistonretention member 546 extends into the gap 584 of the piston 506 tosecure the piston 506 in place on the piston retention member 546.

The safety arm springs 510 bias the safety arms 508, 509 axiallydownwardly such that the lower ends 556 of the safety arms 508, 509extend downwardly from the second step portion 534 into the first stepportion 530 of the stepped bore 528. This enables the piston lockingarms 558, and in particular, the protrusions 560 extending therefrom, tobe positioned adjacent the upper ends 582 of the tapered arms 576. Insuch an orientation, the piston 506 is prevented from being displacedfrom the piston retention member 546 by the piston locking arms 558.

To use the applicator 500 with the fluid delivery apparatus 10, as isdescribed herein, the user attaches the attachment band 430 and thefluid delivery apparatus 10 to the user's body. In particular, theattachment band 430 is stretched and tightened around the user's body,such as an arm or wrist of the user. The band provides a generally axialforce to the fluid delivery apparatus 10, generally along the centralaxis “A.” The force of the fluid delivery apparatus 10 against theuser's body facilitates causes the portion of the user's skin beneaththe fluid delivery apparatus 10 to form a crown within the colletassembly 12. The collet assembly 12 also facilitates maintaining anappropriate amount of deformation (strain) of the user's skin during useof the fluid delivery apparatus 10. The indicator 444, which is visiblethrough the window 61 of the first coupling member 66, presents a visualindication to the user that indicates when the attachment band 430 isstretched enough to impart the proper amount of force to the fluiddelivery apparatus 10. The skin deformation and the crowning of theportion of the user's skin encircled by the collet assembly 12facilitate proper penetration of the microneedle array assembly 108 intothe user's skin.

The applicator 500 is positioned onto the fluid delivery apparatus 10 asshown in FIG. 48. The upper wall 30 of the collet assembly 12 isdisposed into the first step portion 530 of the stepped bore 528. Theupper wall 30 contacts the lower ends 556 of the safety arms 508, 509.As the user applies downward pressure to the applicator 500, the safetyarms 508, 509 are displaced axially upwardly in the channels 550 suchthat the piston locking arms 558 are displaced away from the upper ends582 of the tapered arms 576. The user presses the button 504 to releasethe piston 506. In particular, as the button 504 is pressed, theinclined face 594 of the button release member 592 slidingly engages theupper inclined face 586 of the piston hanger 570. As the button ispressed further down, the upper inclined face 586 of the piston hanger570 is displaced transversely to the central axis “E” of the applicator500. When the bridge portion 580 disengages from the piston retentionmember 546, the piston spring 512 forces the piston 506 axiallydownwardly within the housing 502. The piston 506 contacts the threadedadjustment member 370 of the mechanical controller assembly 20 todisplace the fluid delivery apparatus 10 from the pre-use configurationshown in FIG. 1A to the pre-activated configuration shown in FIG. 1B.

As described herein, the piston has a predetermined mass that enablesthe piston 506 to achieve a desirable velocity and impulse rate duringuse of the applicator 500 to properly activate the fluid deliveryapparatus 10 for use. In the exemplary embodiment, the mass of thepiston 506 and the spring force of the piston spring 512 combine toprovide a momentum or impulse of the piston 506 greater than about 0.05newton seconds (Ns), and a kinetic energy of the piston 506 greater thanabout 0.1 kilogram meters²/second² (kg·m²/s²) or joules (J) at impactwith the threaded member 370 of the mechanical controller assembly. Thepiston contacts the mechanical controller assembly 20 with apredetermined velocity and impulse rate to overcome the mechanicalproperties of the fluid delivery apparatus 10 such that the plurality ofmicroneedles 234 of the microneedle array assembly 108 are acceleratedtoward and properly inserted into the user's skin. In one suitableembodiment, the microneedle array assembly 108 is configured to impactthe user's skin at a velocity of at least about 4 meters/second (m/s).Alternatively, the microneedle array assembly 108 is configured toimpact the user's skin at any velocity that enables the microneedlearray assembly 108 to be properly inserted into the user's skin.

After the fluid delivery apparatus 10 is properly attached to the userand configured in the pre-activated configuration shown in FIG. 1B, theuser can activate the fluid delivery apparatus 10 by pressing thepivoting latches 368 to release the plunger component 362. In oneembodiment, the user may use a tool (not shown) configured tosimultaneously press the pivoting latches 368. When the pivoting latches368 are pressed, the pivot about the cylindrical pins 452 such that theconcave cutouts 458 of the latch portions 456 pivot into axial alignmentwith the central axis “A.” This enables the plunger component 362 todisengage from the pivoting latches 368 and contact the upper sealingmember 280 of the cartridge assembly 18.

In the exemplary embodiment, the biasing assembly 364 functions to applyan axial two stage force profile to the plunger component 362 during useof the fluid delivery apparatus 10. In particular, when the plungercomponent 362 is released, the second biasing member 378 and the firstbiasing member 372 apply force to the plunger component 362, i.e., afirst force profile. As illustrated in FIG. 1B, the axial location ofthe upper ends of the second biasing member 378 and the first biasingmember 372 are axially displaced with respect to each other. Further, asdescribed herein, the second biasing member 378 and the first biasingmember 372 have different lengths and force constants, thus the axialforce applied to the plunger component 362 changes with respect to thedisplacement of the plunger component 362.

Initially, as the plunger component 362 is displaced axially by thebiasing assembly 364, the second biasing member 378 and the firstbiasing member 372 are applying force to the plunger component 362. Asthe plunger component 362 is displaced, the second biasing member 378and the first biasing member 372 extend such that the force exerted onthe plunger component 362 decreases. At a predetermined axialdisplacement of the plunger component 362, the second biasing member 378becomes fully extended or is prevented from being extended further bythe threaded fastener 374 and the nut 382. At this position, the firstbiasing member 372 continues to apply a force to the plunger component362, i.e., a second force profile.

In particular, as illustrated in FIG. 1B, the second biasing member 378and the first biasing member 372 are configured to extend axiallydownwardly when the plunger component 362 is released. The first biasingmember 372 and the second biasing member 378 press against the insertcomponent 380, which is positioned against the threaded adjustmentmember 370. As the second biasing member 378 extends downward, thethreaded fastener 374, the tube 376, and the nut 382 move axially withinthe insert component 380. When the nut 382 contacts a top of the insertcomponent 380, the second biasing member 378 is prevented fromexpanding, and therefore, from exerting any force on the plungercomponent 362. The first biasing member 372, however, continues to exertforce until the plunger component 362 is displaced fully against thereservoir component 270 of the cartridge assembly 18.

The pressure applied to the plunger component 362 by the biasingassembly 364 is transmitted to the cartridge assembly 18. The pressurefacilitates displacing the fluid contained in the upper cavity 272through the cannula 104 and into the fluid passage 276. The fluid exitsthe fluid passage 276 by flowing into the plenum cap assembly 106. Inparticular, with reference to FIG. 14, the fluid flows downwardlythrough the aperture 204 of the first adhesive layer 192, the aperture208 of the vent membrane 194, and into the arcuate slot 210 of thesecond adhesive layer 196. The impermeable membrane 198 is coupled tothe bottom of the second adhesive layer 196, thereby preventing thefluid from passing directly therethrough. As such, the pressure appliedby the biasing assembly 364 forces the fluid to fill the arcuate slot210, where it is channeled to the aperture 222 in the impermeablemembrane 198. The fluid passes through the aperture 222 where it entersthe slot 224 formed in the third adhesive layer 200. The fluid ischanneled by the slot 224 to the inlet channel 254 of the microneedlearray assembly 108.

During use of the fluid delivery apparatus 10, gas and/or air may bemixed or become mixed with the fluid. As such, the plenum cap assembly106 is configured to facilitate removing such gas and/or air from thefluid. As the fluid is force through the arcuate slot 210, the pressurefacilitates removing the gas from the fluid. In particular, the fluidfills the arcuate slot 210 such that it contacts the vent membrane 194positioned above the second adhesive layer 196. The gas and/or airdispersed through the fluid is forced upward toward the vent membrane194, where it passes therethrough. As described herein, the ventmembrane 194 is fabricated from a gas permeable oleophobic/hydrophobicmaterial, such that the gas and/or air passes through, but the fluidcannot. The gas and/or air then passes through the slot 202 of the firstadhesive layer 192. The arcuate slot 202 is configured to at leastpartially correspond to the arcuate channel 176 of the plenum component102, such that the gas and/or air may be vented out of the fluid flowand into the internal chamber 167 of the plenum component 102. Asdescribed herein, the plenum component 102 is configured to attach tothe cartridge assembly 18, thereby facilitating creating a sterileinternal chamber 167 for receiving the vented gas.

The fluid is channeled to the inlet channel 254 of the microneedle arrayassembly 108, substantially free of gas and/or air bubbles. The fluidenters the distribution manifold 238, and then the fluid flows throughthe supply channels 256, the resistance channels (not shown), and theoutlet channels 258 to the passageways 246 of the microneedles 234 andinto the user's skin. In the exemplary embodiment, the biasing assembly364 functions in connection with the plunger component 362 to providesubstantially complete emptying of the fluid from the cartridge assembly18 through the cannula 104 and into the fluid passage 276. The plungercomponent 362 and the biasing assembly 364 may provide an initial forcein a range of about 32 kilopascals (kPa) (4.6 pounds per square inch(psi)) to about 150 kPa (21.8 psi).

In the exemplary, embodiment, the mathematical representation of theforce provided to the plunger component 362 by the biasing assembly 364is the sum of the force from the first biasing member 372 and the secondbiasing member 378:

F(x)=FM(x)+FT(x)  Equation 1:

Where FM(x) equals the force from the first biasing member 372 innewtons as a function of position in millimeters, and where FT(x) equalsthe force from second biasing member 378 in newtons as a function ofposition in millimeters.

The force from the first biasing member 372 can be represented by twoexpressions, depending on where the plunger component 362 is locatedwith respect to the length of the first biasing member 372:

$\begin{matrix}{{F\; {M(x)}} = \begin{matrix}{K_{m}\left( {L_{m} - \left( {B_{m} - x} \right)} \right)} & {x < {L_{M} - B_{M}}} \\0 & {x \geq {L_{M} - B_{M}}}\end{matrix}} & {{Equation}\mspace{14mu} 2}\end{matrix}$

Where K_(m) equals the force constant of the first biasing member 372,L_(m) equals the length of the first biasing member 372, B_(m) equalsthe base length of the first biasing member 372, and x equals thedisplacement of the plunger component 362 with respect to the length ofthe first biasing member 372.

Similarly the force from second biasing member 378 is:

$\begin{matrix}{{F\; {T(x)}} = \begin{matrix}{K_{T}\left( {L_{T} - \left( {B_{T} - x} \right)} \right)} & {x < {L_{T} - B_{T}}} \\0 & {x \geq {L_{T} - B_{T}}}\end{matrix}} & {{Equation}\mspace{14mu} 3}\end{matrix}$

Where K_(T) equals the force constant of the second biasing member 378,L_(T) equals the length of the second biasing member 378, B_(T) equalsthe base length of the second biasing member 378, and x equals thedisplacement of the plunger component 362 with respect to the length ofthe second biasing member 378.

In the exemplary embodiment, the first biasing member 372 length extendsbeyond the maximum travel of the plunger component 362 such that thecondition described in Equation 2 cannot be met. As such, the firstbiasing member 372 always applies a force to plunger component 362. Inaddition, a length of the second biasing member 378 is predeterminedsuch that the second biasing member 378 discontinues providing force tothe plunger component 362 before the plunger component 362 has reachedits maximum travel. In the exemplary embodiment, the conditionsdescribed in Equation 3 are valid for at least some portion of thetravel of the plunger component 362.

The apparatus, system, and methods described in detail herein enable afluid delivery apparatus to remove gas and/or air from a medicine and todistribute a substantially equal quantity of the medicine through eachmicroneedle of the microneedle assembly. A plenum cap assembly of thefluid delivery apparatus includes a fluid supply channel disposedbetween an impermeable material and a gas permeableoleophobic/hydrophobic material. This facilitates removing the gasand/or air from the medicine while delivering substantially all of themedicine to the user of the fluid delivery apparatus 10. In addition, abiasing assembly enables a pressure profile to be determined tofacilitate optimizing the flow rate and distribution of the medicinethrough a microneedle array assembly over an extended period of time,thereby facilitating a steady state concentration of the fluid that isdelivered to the user. Moreover, the fluid delivery apparatus includes aband or strap that enables the fluid delivery apparatus to beappropriately attached to the user's skin to facilitate optimalinsertion of the microneedles into the user's skin.

Exemplary embodiments of an apparatus, system, and methods for a fluiddelivery apparatus are described above in detail. The apparatus, system,and methods described herein are not limited to the specific embodimentsdescribed, but rather, components of apparatus, systems, and/or steps ofthe methods may be utilized independently and separately from othercomponents and/or steps described herein. For example, the methods mayalso be used in combination with other fluid delivery apparatus,systems, and methods, and are not limited to practice with only theapparatuses, systems, and methods described herein. Rather, theexemplary embodiments can be implemented and utilized in connection withmany fluid delivery applications.

Although specific features of various embodiments of the disclosure maybe shown in some drawings and not in others, this is for convenienceonly. In accordance with the principles of the disclosure, any featureof a drawing may be referenced and/or claimed in combination with anyfeature of any other drawing.

This written description uses examples to disclose the embodiments,including the best mode, and also to enable any person skilled in theart to practice the embodiments, including making and using any devicesor systems and performing any incorporated methods. The patentable scopeof the disclosure is defined by the claims, and may include otherexamples that occur to those skilled in the art. Such other examples areintended to be within the scope of the claims if they have structuralelements that do not differ from the literal language of the claims, orif they include equivalent structural elements with insubstantialdifferences from the literal languages of the claims.

As various changes could be made in the above embodiments withoutdeparting from the scope of the disclosure, it is intended that allmatter contained in the above description and shown in the accompanyingdrawings shall be interpreted as illustrative and not in a limitingsense.

What is claimed is:
 1. An application device for a fluid deliveryapparatus, the application device comprising: a housing having a boreextending from a bottom of the housing, the bore being sized and shapedfor receiving at least a portion of the fluid delivery apparatustherein; an impact component for impacting the fluid delivery apparatusand moving at least a portion of the fluid delivery apparatus towards ausers skin; and a safety arm positionable relative to the impactcomponent between a locked configuration in which the impact componentis secured in a safety position, and a released configuration in whichthe impact component is free to move within the housing for impactingthe fluid delivery apparatus, wherein the housing further comprises aretention member for securing the impact component in the safetyposition, the retention member being a body that extends radially inwardfrom the bore.
 2. The application device in accordance with claim 1further comprising a safety arm biasing device configured to bias thesafety arm in the locked configuration.
 3. The application device inaccordance with claim 1 further comprising an impact component biasingdevice configured to bias the impact component relative to the housing.4. The application device in accordance with claim 3, wherein the impactcomponent biasing device is configured to drive the impact componenttoward the fluid delivery apparatus to facilitate proper actuation ofthe fluid delivery apparatus.
 5. The application device in accordancewith claim 3, wherein the impact component biasing device is a spring.6. The application device in accordance with claim 1, wherein thehousing further comprises a release component configured to release theimpact component when the safety arm is oriented in the releasedconfiguration.
 7. The application device in accordance with claim 1,wherein the housing further comprises an elongated slot formed throughthe housing, the elongated slot configured to receive a portion of theimpact component to facilitate access to and prevent rotation of theimpact component within the housing.
 8. The application device inaccordance with claim 1, wherein the housing further comprises aretaining ring proximate the bottom of the housing, the retaining ringconfigured to retain the impact component and the safety arm within thehousing.
 9. The application device in accordance with claim 1, whereinthe housing further comprises a plurality of axially extending groovesformed in the bore.
 10. The application device in accordance with claim9, wherein the impact component comprises a plurality of protrusions,each protrusion corresponding to a respective axially extending groove.11. The application device in accordance with claim 1, wherein thehousing comprises a longitudinal channel configured to receive thesafety arm in sliding engagement.
 12. (canceled)
 13. (canceled)
 14. Asystem comprising an application device and a fluid delivery apparatus,the application device including a housing having a bore extendingupward from a bottom of the housing, the bore being sized and shaped forreceiving at least a portion of the fluid delivery apparatus therein,the application device has a retention member and an impact componentpositioned within the bore, the retention member being a body thatextends radially inward from the bore, the impact component beingadapted for impacting the fluid delivery apparatus and moving at least aportion of the fluid delivery apparatus toward a user's skin, the impactcomponent being positionable relative to the housing between a safetyposition in which the impact component is secured to the retentionmember, and a released configuration in which the impact component isfree to move within the housing for impacting the fluid deliveryapparatus, the application device has a release component configured totransition the impact component from the safety position to the releasedconfiguration.
 15. The system in accordance with claim 14 wherein theapplication device further comprises a cap configured to couple therelease component to the housing.
 16. The system in accordance withclaim 15 wherein the application device further comprises a releasecomponent biasing device positioned between the release component andthe retention member, the biasing component configured to bias therelease component away from the impact component.
 17. The system inaccordance with claim 14, wherein the impact component of theapplication device further comprises a head portion coupled to a hangerportion.
 18. The system in accordance with claim 17, wherein the hangerportion comprises a pair of upwardly extending tapered arms and a bridgeportion extending between upper ends of the tapered arms.
 19. The systemin accordance with claim 18, wherein the bridge portion engages theretention member in the safety position of the impact component, andwherein the bridge portion is free from the retention member in thereleased configuration of the impact component.
 20. The system inaccordance with claim 18, wherein the release component comprises adownwardly extending inclined surface, and wherein the bridge portioncomprises an upwardly extending inclined surface configured to engagethe downwardly extending inclined surface of the release component tofacilitate release of the impact component from the retention member.21. The system in accordance with claim 14, wherein the impact componentof the application device comprises a predetermined mass that enablesthe impact component to achieve a desirable velocity and impulse rateduring use of the application device to facilitate properly activatingthe fluid delivery apparatus.
 22. The system in accordance with claim21, wherein the application device further comprises an impact componentbiasing device configured to bias the impact component relative to thehousing, wherein the biasing component is configured to apply a force tothe impact component to move at least a portion of the fluid deliveryapparatus toward a user's skin at a velocity of at least about 4meters/second (m/s).
 23. The system in accordance with claim 22, whereinthe impact component biasing device and the predetermined mass of theimpact component provide an impulse force to the fluid deliveryapparatus greater than about 0.05 newton seconds (Ns).
 24. The system inaccordance with claim 22, wherein the impact component biasing deviceand the predetermined mass of the impact component provide a kineticenergy of the impact component greater than about 0.1 joules (J). 25.The system in accordance with claim 14, wherein the fluid deliveryapparatus comprises a microneedle array comprising a plurality ofmicroneedles.
 26. The system in accordance with claim 25, wherein anoverall length of each microneedle of the plurality of microneedles isless than about 1000 micrometers.
 27. The system in accordance withclaim 25, wherein a quantity of microneedles of the plurality ofmicroneedles is in the range between about 10 microneedles per squarecentimeter (cm²) to about 1,500 microneedles per cm².
 28. A method ofactivating a fluid delivery apparatus having a fluid therein and aplurality of microneedles for delivering the fluid to a user via theplurality of microneedles, the method comprising: positioning the fluiddelivery apparatus relative a portions of the user's body such that theplurality of microneedles are adjacent the user's skin; positioning anapplication device into direct contact with the fluid deliveryapparatus; and activating the application device to cause a piston ofthe application device to contact the fluid delivery apparatus at apredetermined velocity and drive the plurality of microneedles into theuser's skin at a velocity in the range between 4.5 meters/second (m/s)to 6 m/s.
 29. The method of claim 28 further comprising activating thefluid delivery apparatus to deliver the fluid to the user via theplurality of microneedles.